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Manual TX driver vertical- Standard
EUDAMEDClass I (EU MDR)
Ref 5478Model Drivers
Identity
- Trade Name
- Manual TX driver vertical- Standard EUDAMED
- Model / Reference
- Drivers EUDAMED5478 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290120462809 EUDAMED
- Basic UDI-DI
- 72901178DrivZK EUDAMED
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Manual TX driver vertical- Standard by Alpha Bio Tec 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 | 72901178DrivZK | Class I | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- EUDAMED SRN
- IL-MF-000021145
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 7e3afcbc-a54e-4902-8bd0-9cc34c0120c3 61 fields · synced Jul 31, 2026
- EUDAMED 73860b16-e6ce-4472-9298-e9a98f0a00d1 61 fields · synced Jul 31, 2026