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Breitfixierpflaster
EUDAMEDClass I (EU MDR)
Ref 190202Ref 138946Ref 138945Ref 190201Ref 190200Ref 138942
Identity
- Trade Name
- Breitfixierpflaster EUDAMED
- Device Name
- Medical dressing roll EUDAMED
- Model / Reference
- 190202 EUDAMED138946 EUDAMED138945 EUDAMED190201 EUDAMED190200 EUDAMED138942 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926515403010 EUDAMED06926515402952 EUDAMED06926515402938 EUDAMED06926515402990 EUDAMED06926515402976 EUDAMED06926515402877 EUDAMED
- Basic UDI-DI
- 69593857MDR000001CB EUDAMED
- EMDN Code
- M04010201 NON-WOVEN FIXING DRESSINGS 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
Breitfixierpflaster 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 | 69593857MDR000001CB | 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 cb1e1a1e-ee94-4c74-96ff-2e536877fe36 61 fields · synced Aug 3, 2026
- EUDAMED 4096fced-43ed-40db-b217-03a57e4ee1d1 61 fields · synced May 17, 2026
- EUDAMED cc477ccc-4146-419c-aaf0-b8758163794d 61 fields · synced May 17, 2026
- EUDAMED def7733d-fc16-4dd1-a62b-8becaef33410 61 fields · synced May 17, 2026
- EUDAMED d508f612-cf82-4b7b-8a75-73ebd0bf8e61 61 fields · synced May 18, 2026
- EUDAMED 25bba4f1-25fc-49fc-bf31-52585edbb019 61 fields · synced May 18, 2026