Identity
- Trade Name
- Probe with handle EUDAMED
- Device Name
- Probe and Sizing block EUDAMED
- Model / Reference
- ZXCL EUDAMEDZXCL3001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486983041 EUDAMED
- Basic UDI-DI
- 697348698ZXCL2F EUDAMED
- EMDN Code
- L1921 ARTHROSCOPIC SURGERY PROBES, 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
Probe with handle 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 | 697348698ZXCL2F | 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 d0859f8a-7ad5-4ac7-a2c2-81a13cb8a312 61 fields · synced Oct 6, 2026