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Pansement hydrocolloïde stérile
EUDAMEDClass IIb (EU MDR)
Ref HCL1212-10Ref HCL1015-10Ref HCL0507-10Ref HCL2020-10Ref HCL1010-10
Identity
- Trade Name
- Pansement hydrocolloïde stérile EUDAMED
- Device Name
- Hydrocolloid Dressing EUDAMED
- Model / Reference
- HCL1212-10 EUDAMEDHCL1015-10 EUDAMEDHCL0507-10 EUDAMEDHCL2020-10 EUDAMEDHCL1010-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615370005158 EUDAMED03615370005141 EUDAMED03615370005110 EUDAMED03615370005165 EUDAMED03615370005134 EUDAMED
- Basic UDI-DI
- 694109403536EU EUDAMED
- Unit of Use DI
- 13615370005155 EUDAMED13615370005148 EUDAMED13615370005117 EUDAMED13615370005162 EUDAMED13615370005131 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Pansement hydrocolloïde stérile by Winner Medical Co., Ltd. — Class IIb — 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 | 694109403536EU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 0390aaba-3009-454b-a43f-43325386ec6b 61 fields · synced Jul 31, 2026
- EUDAMED f1bd046b-0177-49ba-9e9a-69ceaffce583 61 fields · synced May 17, 2026
- EUDAMED 9a63aab4-dc6e-4167-b17f-c94d48d8e08b 61 fields · synced May 17, 2026
- EUDAMED d03bbe73-1624-42a9-a137-36fd2276518d 61 fields · synced May 18, 2026
- EUDAMED eab9ceea-0288-4d7a-90f7-aa809aea5812 61 fields · synced May 18, 2026