← Back to catalogue
4PRAX med sterilWundverband
EUDAMEDClass I (EU MDR)
Ref 718003FPRef 718006FPRef 718012FP
Identity
- Trade Name
- 4PRAX med sterilWundverband EUDAMED
- Device Name
- Sterile Adhesive Surgical Dressing EUDAMED
- Model / Reference
- 718003FP EUDAMED718006FP EUDAMED718012FP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262495682703 EUDAMED04262495682765 EUDAMED04262495682673 EUDAMED
- Basic UDI-DI
- 69593857SASD0000013M EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
4PRAX med sterilWundverband 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED e9da03ff-e9a3-4fee-86ac-e687ff8512b7 61 fields · synced Jul 28, 2026
- EUDAMED 019753ea-1929-4376-9a3a-fa511e3d0fe8 61 fields · synced May 18, 2026
- EUDAMED b05f8a60-9d20-4800-9a40-5926c3a17361 61 fields · synced May 19, 2026