Identity
- Trade Name
- Tibial aimer handle EUDAMED
- Device Name
- Drill aimer EUDAMED
- Model / Reference
- ZXMZ EUDAMEDZXMZ2502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486983621 EUDAMED
- Basic UDI-DI
- 697348698ZXMZ110377 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Tibial aimer handle by Qingdao Zhixing Medical Instrument Co., Ltd. — Class I — CE/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 | 697348698ZXMZ110377 | Class I | Active |
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Manufacturer
- Manufacturer
- Qingdao Zhixing Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000024667
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e1e4d385-3c3c-4eab-bcd3-e068b4f189a9 61 fields · synced Oct 6, 2026