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Aquasite Hydrogel Impregnated Gauze Dressing
EUDAMEDClass IIa (EU MDR)
Ref 53044Model Aquasite Hydrogel Wound Dressings
Identity
- Trade Name
- Aquasite Hydrogel Impregnated Gauze Dressing EUDAMED
- Model / Reference
- Aquasite Hydrogel Wound Dressings EUDAMED53044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00809958051702 EUDAMED
- Basic UDI-DI
- 0809958MDRTD0038L EUDAMED
- Direct Marketing DI
- 00809958051702 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 Gauze 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 7ea05f04-d0db-402b-b5da-9ea2d61a1af0 61 fields · synced Jun 18, 2026