Identity
- Trade Name
- Hex Driver 1.25mm EUDAMED
- Model / Reference
- Drivers EUDAMED4055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117811313 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
Hex Driver 1.25mm 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 79db99b5-e5a6-40bc-8d3a-b09407efe6c6 61 fields · synced Jul 9, 2026
- EUDAMED f5c7bb70-46c0-413d-913f-e30c67329fd0 61 fields · synced Jul 9, 2026