Identity
- Trade Name
- Suture passer hook EUDAMED
- Device Name
- Knot pusher and Suture passer hook EUDAMED
- Model / Reference
- ZXDJ EUDAMEDZXDJ2003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486983409 EUDAMED
- Basic UDI-DI
- 697348698ZXDJ2E EUDAMED
- EMDN Code
- L031309 SUTURE NEEDLE PASSERS, 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
Suture passer hook 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 | 697348698ZXDJ2E | 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 b6b403ab-da5f-48ce-a55d-678a93d9beb4 61 fields · synced Oct 6, 2026