Identity
- Device Name
- External fixation device EUDAMED
- Model / Reference
- HA4 EUDAMEDHA530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925959309322 EUDAMED
- Basic UDI-DI
- 69259593HAHC EUDAMED
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 device 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 | 69259593HAHC | 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 a1fcbcf8-8932-4530-b008-db6c68f86fa6 61 fields · synced Jul 16, 2026