Identity
- Trade Name
- Sterilization Wrap EUDAMED
- Device Name
- Sterilization Wrap EUDAMED
- Model / Reference
- BL1015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237112368 EUDAMED
- Basic UDI-DI
- 48952371515VV EUDAMED
- EMDN Code
- S010302 NON-WOVEN FABRIC FOR STERILISATION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sterilization Wrap by Kenpax International Limited — 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 | 48952371515VV | Class I | Active |
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Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 596551d6-001f-4202-b5c9-c98cf53eaee7 61 fields · synced Jun 18, 2026