Identity
- Trade Name
- Bengun W/O Screws EUDAMED
- Device Name
- CRW Non-XY frame Mechanical Set KIT EUDAMED
- Model / Reference
- 700-020834-00 EUDAMED700-000307-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290114061278 EUDAMED
- Basic UDI-DI
- 729011406123MECHB EUDAMED
- Direct Marketing DI
- 07290114061278 EUDAMED
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER 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
Bengun W/O Screws by Alpha Omega Engineering 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 | 729011406123MECHB | Class I | Active |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Ltd
- EUDAMED SRN
- IL-MF-000025214
- Authorised Representative
- Alpha Omega GmbH DE-AR-000022420
Sources (1)
- EUDAMED 4c7d67e7-8dd2-4ad4-a5a7-7e30b4bc16a4 61 fields · synced Jun 18, 2026