Certificate number:
FM 68740
Scope: The manufacture of tapes, dressings, wraps, films, drapes, closures, sterilization indicator systems, hot and cold packs and defib pads.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 13485:2016 |
2002-07-30 |
2028-09-01 |
Certificate number:
MDSAP 632042
Scope: The manufacture of tapes, dressings, wraps, films, drapes, closures, sterilization indicator systems, hot and cold packs and defib pads.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| MDSAP |
2016-09-16 |
2025-09-01 |
Certificate number:
KM 657624
Scope: Sterilization of health care products.
Biological indicators.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| BS EN ISO 11138 Biological Indicators |
2016-10-03 |
2025-09-01 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| (EU) 2017/745 Annex IX Chapter I and III |
2022-10-06 |
2027-10-05 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| Art 22 (EU) 2017/745 Annex XI Part A |
2022-02-07 |
2027-02-06 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| (EU) 2017/745 Annex XI Part A |
2021-02-08 |
2026-02-07 |
Certificate number:
KM 748341
Scope: Sterilization of Health care products. Chemical indicators
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 11140-1 |
2021-06-15 |
2028-09-01 |
Certificate number:
UKCA 763340
Scope: The design and manufacture of electrosurgical plates, sterile medicated drapes, sterile medicated transparent film dressings, ethylene oxide gas sterilizers and cartridges, temperature monitoring sensors and controller, pressure infusion regulators, blood/fluid warming units, fluid warming units and sterile disposable sets for irrigation, and patient warming units.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| UK MDR Part II Annex II Sec 3.2 |
2023-01-04 |
2030-03-16 |
Certificate number:
UKCA 763342
Scope: The manufacture and final inspection of sterile transparent wound dressings, barrier film dressings, and sterile disinfecting port protector devices.
Those aspects of Annex V relating to securing and maintaining sterility of wound dressings, barrier film wraps, patient warming blankets and securement devices.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| UK MDR Part II Annex V Sec 3.2 |
2022-12-20 |
2030-03-15 |
Certificate number:
FM 14552
Scope: The manufacturer of microbiological testing products.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 9001:2015 |
1992-02-14 |
2028-09-01 |
Certificate number:
CE 00493
Scope: The manufacture of sterile wound dressings, drapes, barrier films and defib pads and sub-contracted sterilzation of medical devices
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| 93/42/EEC Annex V, Section 3.2 (2007/47) |
1995-02-01 |
2024-05-26 |
Certificate number:
CE 02242
Scope: The design and manufacture of electrosurgical plates, sterile medicated drapes, sterile medicated transparent film dressings, ethylene oxide gas sterilizers and cartridges, temperature monitoring sensors and controller, pressure infusion regulators, blood/fluid warming units and sterile disposable sets for infusion, fluid warming units and sterile disposable sets for irrigation, and patient warming units.
The design and manufacture of sterile wound dressings (non-medicated):
- adhesive foam
- non-adhesive foam
- hydrocolloid
- alginate
- absorbent clear acrylic
- non adherent
- hydrogels
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| 93/42/EEC Annex II, Sec 3.2 (2007/47) |
1999-02-12 |
2024-05-26 |
