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Aquasite Hydrogel Impregnated Non-Woven Dressing
EUDAMEDClass IIa (EU MDR)
Ref 81122Model Aquasite Hydrogel Wound Dressings
Identity
- Trade Name
- Aquasite Hydrogel Impregnated Non-Woven Dressing EUDAMED
- Model / Reference
- Aquasite Hydrogel Wound Dressings EUDAMED81122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00809958084403 EUDAMED
- Basic UDI-DI
- 0809958MDRTD0038L EUDAMED
- Direct Marketing DI
- 00809958084403 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aquasite Hydrogel Impregnated Non-Woven Dressing by Derma Sciences Canada, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0809958MDRTD0038L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
- EUDAMED SRN
- CA-MF-000048991
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 094eb0ea-9613-4b63-8ca4-ade7b12189ba 61 fields · synced Aug 2, 2026