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Alpha Step Drill_3.65/4.1
EUDAMEDClass IIa (EU MDR)
Ref 4596Model Drills and Motor mounts
Identity
- Trade Name
- Alpha Step Drill_3.65/4.1 EUDAMED
- Model / Reference
- Drills and Motor mounts EUDAMED4596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117814864 EUDAMED
- Basic UDI-DI
- 729011781DrillsMotormouXX EUDAMED
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Alpha Step Drill_3.65/4.1 by Alpha Bio Tec Ltd. — Class IIa — 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 | 729011781DrillsMotormouXX | Class IIa | 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 (1)
- EUDAMED 611ceaad-de61-4c98-a8e6-ded2ca0323b6 61 fields · synced Jul 12, 2026