Identity
- Device Name
- External fixation devices EUDAMED
- Model / Reference
- DA1 EUDAMEDD101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925959300015 EUDAMED
- Basic UDI-DI
- 69259593DAGY EUDAMED
- EMDN Code
- P0912040102 AXIAL BONE FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
External fixation devices by Aike (Shanghai) Medical Instrument Co., 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 | 69259593DAGY | Class I | Active |
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Manufacturer
- Manufacturer
- Aike (Shanghai) Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000017162
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e9327bdc-fd09-4f79-b050-7925e1d8fd84 61 fields · synced Jul 8, 2026