Identity
- Trade Name
- Femoral drill EUDAMED
- Device Name
- Surgical Drills EUDAMED
- Model / Reference
- ZXZT EUDAMEDZXZT1025 EUDAMEDZXZT1028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486983447 EUDAMED06973486983454 EUDAMED
- Basic UDI-DI
- 697348698ZXZT54 EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS 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
Femoral drill by Qingdao Zhixing 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 | 697348698ZXZT54 | 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 (2)
- EUDAMED ce8f44be-bd55-4e3d-b203-9b5b8cb31c5b 61 fields · synced Oct 6, 2026
- EUDAMED 6d277ebe-73f6-4164-91b0-f80d5f10fcb0 61 fields · synced May 17, 2026