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FiIm adhésif transparent stérile
EUDAMEDClass I (EU MDR)
Ref K85101501K-4Ref K85101501K-3Ref 6942273346048Ref K85101501K-6Ref 6942273346062Ref 6942273382336
Identity
- Trade Name
- FiIm adhésif transparent stérile EUDAMED
- Device Name
- Sterile Adhesive Surgical Dressing EUDAMED
- Model / Reference
- K85101501K-4 EUDAMEDK85101501K-3 EUDAMED6942273346048 EUDAMEDK85101501K-6 EUDAMED6942273346062 EUDAMED6942273382336 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942273372443 EUDAMED06942273372436 EUDAMED06942273346048 EUDAMED06942273388789 EUDAMED06942273346062 EUDAMED06942273382336 EUDAMED
- Basic UDI-DI
- 69593857SASD0000013M EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
FiIm adhésif transparent stérile by Zhende Medical Co., Ltd. — Class I — 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 | 69593857SASD0000013M | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED bcdd96bd-1dc2-41f1-a9c0-4e60c9ef1cd9 61 fields · synced Jul 29, 2026
- EUDAMED 37081300-b32b-44be-a962-73a52002994e 61 fields · synced May 16, 2026
- EUDAMED c5c5fcd2-2b9a-4142-ad51-09cff42b32c9 61 fields · synced May 16, 2026
- EUDAMED cb65dd5d-7e84-4ac2-887d-b67429389307 61 fields · synced May 18, 2026
- EUDAMED 0f393092-9ce5-47bc-8d95-06c51e585972 61 fields · synced May 18, 2026
- EUDAMED a3116ed7-97bb-4fa9-9fcc-ce2929f69cc3 61 fields · synced May 19, 2026