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Check company, site and product certificates - Validation and Verification
Certificate number:
FM 68740
Scope: The manufacture of blood/fluid warming products, irrigation fluid warming products, patient warming blankets, patient warming units, pressure infuser units, temperature monitoring products.
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 blood/fluid warming products, irrigation fluid warming products, patient warming/cooling blankets, patient warming/cooling units, pressure infuser units, sterile patient warming/cooling blankets, temperature monitoring products.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
MDSAP | 2016-09-16 | 2025-09-01 |
Certificate number:
CE 00493
Scope: The manufacture of sterile transparent wound dressings with and without pads, electronic stethoscopes and associated software, sterile skin staplers and sterile drapes (wound protector, isolation bag), barrier film dressings, and sterile disinfecting port protector devices.
Those aspects of Annex V relating to securing and maintaining sterility in the manufacture of wound closures, wound dressings, drapes, barrier film wraps, staple removers, patient warming blankets and securement devices.
Those aspects of manufacturing relating to obtaining sterility in the assembly of procedure packs in accordance with Article 12 of the Medical Device Directive.
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 |