Identity
- Trade Name
- SHINVA EUDAMED
- Device Name
- Reusable Surgical Forceps/Tweezers/Needle Holders EUDAMED
- Model / Reference
- ZM077R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936506340811 EUDAMED
- Basic UDI-DI
- 69365063XHSI02WA EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, 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
Category: Suturing needle holder, reusable
Shinva by Xinhua Surgical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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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 | 69365063XHSI02WA | 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 39fe6be0-706d-4cda-807a-94a821a67191 61 fields · synced May 22, 2026