Certificate number:
CE 553828
Scope: Design, development and manufacture of Sterile Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| 93/42/EEC Annex II, Sec 3.2 (2007/47) |
2009-10-07 |
2024-05-26 |
Certificate number:
CE 554050
Scope: Design, development and manufacture of suction handles.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| 93/42/EEC Annex II, Sec 3.2 (2007/47) |
2009-10-07 |
2024-05-26 |
Certificate number:
CE 653527
Scope:
For the manufacture of gloves to the standards specified on the continuation sheet
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2016-09-14 |
2028-07-03 |
Certificate number:
CE 687060
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Orthopaedic Sterile Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-20 |
2029-02-20 |
Certificate number:
CE 687061
Scope: Neoprene surgical gloves for personal protection.
Model: Protexis® Neoprene Essential Sterile Synthetic Neoprene Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-01-16 |
2029-01-16 |
Certificate number:
CE 690473
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Classic Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-19 |
2029-02-19 |
Certificate number:
CE 690527
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI with Neu-Thera® Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-07 |
2029-03-07 |
Certificate number:
CE 690788
Scope: Neoprene surgical gloves for personal protection.
Model: Protexis® Neoprene Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-01-16 |
2029-01-16 |
Certificate number:
CE 690982
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Classic Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-04 |
2029-02-04 |
Certificate number:
CE 691590
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Blue with Neu-Thera® Sterile Latex Powder-Free Surgical Gloves with Nitrile and Emoliient Coatings.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-07 |
2029-03-07 |
Certificate number:
CE 691599
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Ortho Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-14 |
2029-03-14 |
Certificate number:
CE 691606
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex with Neu-Thera® Sterile Latex Powder-Free Surgical Gloves with Nitrile and Emolient Coatings.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-21 |
2029-03-21 |
Certificate number:
CE 691607
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Hydrogel Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-21 |
2029-03-21 |
Certificate number:
CE 693852
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Micro Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-18 |
2029-02-18 |
Certificate number:
CE 693860
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-15 |
2029-02-15 |
Certificate number:
CE 693918
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Blue with Neu-Thera® Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-18 |
2029-03-18 |
Certificate number:
CE 694147
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Micro Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-04 |
2029-02-04 |
Certificate number:
CE 694206
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Essential Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-18 |
2029-02-18 |
Certificate number:
CE 694211
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-02-04 |
2029-02-04 |
Certificate number:
MDSAP 694714
Scope: Legal Manufacturer of medical devices including: infection control apparel, face masks, gowns, drapes, surgical gloves, examination gloves, ice bags, irrigation and suction instruments and accessories, isolation bags, wound drainage systems, procedure trays and packs for clinical and surgical use, hot and cold therapy products, respiratory, gastrointestinal management, blood and specimen collection, thermometry, IV access, cardio-thoracic care, needles, vascular therapy, urology, OR/surgical suction, wound care, airway management, incontinence, maternity care, diagnostics, sharps disposal, operating room support products, hydrogel and petrolatum wound dressings, hydrogel membranes, sterilization wraps and wound treatment systems and related accessories, syringes, biomedical electrode, blood collection tubes, probe covers, dialysis/vascular catheters and related accessories to facilitate dialysis catheter insertion, stainless steel guidewires, urinary bags, urinary catheters, urine meter foley trays, foley catheter trays, urethral catheter trays, universal catheterization trays, tracheostomy trays, staple removal trays, suction catheter and midstream catch trays, connection tubes, drain bags, cardiothoracic drainage, gastrointestinal and feeding tubes, blood collection sets, specimen containers, enteral feeding devices, vascular compression devices including vascular compression sleeves and lead wires, infusion sets for the area of vascular therapy, urology drainage systems, endotracheal tubes and feeding sets, suction accessories, catheters, wound care and closure devices, and stylet catheters to treat venous reflux, thermometers and negative pressure wound therapy devices.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| MDSAP |
2020-04-08 |
2026-01-03 |
Certificate number:
CE 695832
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Ortho Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-03-21 |
2029-03-21 |
Certificate number:
FM 702022
Scope: Legal Manufacturer of medical devices including: infection control apparel, face masks, gowns, drapes, surgical gloves, examination gloves, ice bags, irrigation and suction instruments and accessories, isolation bags, wound drainage systems, procedure trays and packs for clinical and surgical use, hot and cold therapy products, respiratory, gastrointestinal management, blood and specimen collection, thermometry, IV access, cardio-thoracic care, needles, vascular therapy, urology, OR/surgical suction, wound care, airway management, incontinence, maternity care, diagnostics, sharps disposal, operating room support products, hydrogel and petrolatum wound dressings, hydrogel membranes, sterilization wraps and wound treatment systems and related accessories, syringes, biomedical electrode, blood collection tubes, probe covers, dialysis/vascular catheters and related accessories to facilitate dialysis catheter insertion, stainless steel guidewires, urinary bags, urinary catheters, urine meter foley trays, foley catheter trays, urethral catheter trays, universal catheterization trays, tracheostomy trays, staple removal trays, suction catheter and midstream catch trays, connection tubes, drain bags, cardiothoracic drainage, gastrointestinal and feeding tubes, blood collection sets, specimen containers, enteral feeding devices, vascular compression devices including vascular compression sleeves and lead wires, infusion sets for the area of vascular therapy, urology drainage systems, endotracheal tubes and feeding sets, suction accessories, catheters, wound care and closure devices, and stylet catheters to treat venous reflux, thermometers and negative pressure wound therapy devices, medical devices for recording signals and electrosurgical systems return electrodes and biofeedback device.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 13485:2016 |
2009-07-06 |
2026-01-03 |
Certificate number:
CE 705253
Scope: Powder-free surgical gloves for personal protection.
Various models of Protexis™ Surgical Gloves - see continuation sheet.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2019-12-04 |
2029-12-04 |
Certificate number:
UKCA 755478
Scope: For the manufacture of protective gloves to the standards specified on the continuation sheet
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755483
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Orthopaedic Sterile Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755487
Scope: Neoprene surgical gloves for personal protection.
Model: Protexis® Neoprene Essential Sterile Synthetic Neoprene Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755489
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Classic Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755494
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI with Neu-Thera® Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755498
Scope: Neoprene surgical gloves for personal protection.
Model: Protexis® Neoprene Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755501
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Classic Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755502
Scope: Powder-free surgical gloves for personal protection.
Various models of Protexis® Surgical Gloves - see continuation sheet.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-21 |
2027-11-21 |
Certificate number:
UKCA 755503
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Ortho Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755505
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex with Neu-Thera® Sterile Latex Powder-Free Surgical Gloves with Nitrile and Emolient Coatings.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755507
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Hydrogel Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755512
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Micro Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755516
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Sterile Polyisoprene Powder-Free Surgical Gloves.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755517
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Blue with Neu-Thera® Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755518
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Micro Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755519
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Essential Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755520
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755521
Scope: Latex surgical gloves for personal protection.
Model: Protexis® Latex Ortho Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 755522
Scope: Polyisoprene surgical gloves for personal protection.
Model: Protexis® PI Textured Sterile Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Protective gloves |
2022-11-18 |
2027-11-18 |
Certificate number:
UKCA 768723
Scope: Design, manufacture and final inspection of sterile surgical gloves, sterile pneumology instruments for removal of secretions, sterile tubular devices, sterile magnetic drapes, sterile gauzes, sterile nutrition and infusion bags and containers, sterile needles, sterile gastrointestinal tubes, enteral feeding pumps, sterile and non-sterile enteral feeding pump tubing sets and sterile and non-sterile nasogastric tubes.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| UK MDR Part II Annex II Sec 3.2 |
2022-09-28 |
2025-05-26 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| (EU) 2017/745 Annex IX Chapter I and III |
2024-02-27 |
2029-02-26 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| (EU) 2017/745 Annex XI Part A |
2024-02-21 |
2029-02-20 |
