Identity
- Trade Name
- SURGICAL DRILLS EUDAMED
- Device Name
- ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- Model / Reference
- ZXZT1032 EUDAMEDZXZT1009 EUDAMEDZXZT1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486982969 EUDAMED06973486982815 EUDAMED06973486982822 EUDAMED
- Basic UDI-DI
- 697348698ZXZT1032AG EUDAMED697348698ZXZT1009AM EUDAMED697348698ZXZT1011A8 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
Surgical Drills 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 | 697348698ZXZT1032AG | 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 (3)
- EUDAMED 23fbb738-5bb3-4797-86ec-86d8c56a13bf 61 fields · synced Oct 6, 2026
- EUDAMED fd5f925b-4eb5-4f33-93f0-3260f2d7c315 61 fields · synced May 17, 2026
- EUDAMED 3bc103dc-e39b-4f09-8e38-238be87b62fd 61 fields · synced May 18, 2026