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Barrier Film
EUDAMEDClass I (EU MDR)
Ref 1A6535-PModel 1A6535, 1A6536,1A6537,1A6538.1A6536-SB,1A6535-P,1A6536-P,1A6537-P, 1A6538-PRef 1A6536-SBModel Color, transparent, stick/non-stick edge
Identity
- Trade Name
- Barrier Film EUDAMED
- Device Name
- Barrier Film EUDAMED
- Model / Reference
- 1A6535, 1A6536,1A6537,1A6538.1A6536-SB,1A6535-P,1A6536-P,1A6537-P, 1A6538-P EUDAMED1A6535-P EUDAMEDColor, transparent, stick/non-stick edge EUDAMED1A6536-SB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493108329 EUDAMED06952367913810 EUDAMED
- Basic UDI-DI
- 697749310010042VC EUDAMED69523679010042YP EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain 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
Barrier Film by Shanghai Dochem Industries 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 | 697749310010042VC | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 76bac4c5-7a22-4ce4-ad4b-5937c9829f96 61 fields · synced Oct 6, 2026
- EUDAMED e44f18af-1175-4081-99ce-e9ef6868c70b 61 fields · synced May 18, 2026