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NexDrive MicroelectrodeHolder
EUDAMEDClass I (EU MDR)
Ref 700-000316-00Model 700-020834-00
Identity
- Trade Name
- NexDrive MicroelectrodeHolder EUDAMED
- Device Name
- CRW Non-XY frame Mechanical Set KIT EUDAMED
- Model / Reference
- 700-020834-00 EUDAMED700-000316-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290114064729 EUDAMED
- Basic UDI-DI
- 729011406123MECHB 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
NexDrive MicroelectrodeHolder 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 f5de81f7-0727-48e3-8c06-9f7a71bb7a6f 61 fields · synced Jun 18, 2026