Identity
- Trade Name
- Leukoplast® hypafix® EUDAMED
- Device Name
- Hypafix® / Leukoplast® hypafix® EUDAMED
- Model / Reference
- 79949-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042809591309 EUDAMED
- Basic UDI-DI
- 40428094003292898 EUDAMED
- EMDN Code
- M050201 EXTENSIBLE NON-WOVEN PLASTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Leukoplast® hypafix® by BSN medical GmbH — 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 | 40428094003292898 | Class I | Active |
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Manufacturer
- Manufacturer
- BSN medical GmbH
- EUDAMED SRN
- DE-MF-000005787
Sources (1)
- EUDAMED 5d9b6518-f494-499d-a665-dff91ed648a9 61 fields · synced Aug 1, 2026