Identity
- Trade Name
- Sutrue Cutter EUDAMED
- Device Name
- Punch, Forceps, Retriever, Suture Passer EUDAMED
- Model / Reference
- ZXCr EUDAMEDZXCr7401 EUDAMEDZXCr7400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486980361 EUDAMED06973486980354 EUDAMED
- Basic UDI-DI
- 697348698zx001E7 EUDAMED
- EMDN Code
- L1902 ARTHROSCOPIC SURGERY SCISSORS, 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
Sutrue Cutter 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 | 697348698zx001E7 | 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 663da0de-ae3e-4db4-8069-050155bc32a2 61 fields · synced Oct 9, 2026
- EUDAMED 443fdc42-cd5d-4cdd-9e0b-4bfd04c0cde3 61 fields · synced May 17, 2026