Identity
- Trade Name
- SHINVA EUDAMED
- Device Name
- Reusable Surgical Needles/Probes EUDAMED
- Model / Reference
- ZR1961RB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936506399314 EUDAMED
- Basic UDI-DI
- 69365063XHSI05WG EUDAMED
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, 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 | 69365063XHSI05WG | 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 7024eb03-71bd-4672-8daf-6822163edb07 61 fields · synced Oct 5, 2026