Identity
- Trade Name
- SHINVA EUDAMED
- Device Name
- Reusable Surgical Retractors/Spreaders/hooks EUDAMED
- Model / Reference
- ZG281RB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936506301102 EUDAMED
- Basic UDI-DI
- 69365063XHSI04WE EUDAMED
- EMDN Code
- L0509020102 CERVICAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Shinva by Xinhua Surgical 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 | 69365063XHSI04WE | Class I | Active |
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Manufacturer
- Manufacturer
- Xinhua Surgical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000038108
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED b10b930a-88b0-4504-a0e5-c7c9e7930ae7 61 fields · synced May 22, 2026