Identity
- Trade Name
- Osteotome EUDAMED
- Device Name
- Osteotome EUDAMED
- Model / Reference
- ZXGD EUDAMEDZXGD3201 EUDAMEDZXGD2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486983737 EUDAMED06973486983720 EUDAMED
- Basic UDI-DI
- 0697348698ZXGD1001MP EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE 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
Osteotome 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 | 0697348698ZXGD1001MP | 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 d0bcd8ef-3ddc-4f7d-b921-249819f11a1a 61 fields · synced Oct 6, 2026
- EUDAMED 31b4322b-3fd6-4ffc-a526-bc516cc27c55 61 fields · synced May 19, 2026