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Orthodontic Pliers
EUDAMEDClass I (EU MDR)
Ref 4P19Model Fine wire cutting pliers
Identity
- Trade Name
- Orthodontic Pliers EUDAMED
- Device Name
- Orthodontic Pliers EUDAMED
- Model / Reference
- Fine wire cutting pliers EUDAMED4P19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975749083475 EUDAMED
- Basic UDI-DI
- 69420547110SF EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Orthodontic Pliers by Zhejiang Shinye Medical Technology Corp. , 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 | 69420547110SF | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Shinye Medical Technology Corp. , Ltd.
- EUDAMED SRN
- CN-MF-000023934
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8716318c-fea8-4a78-9b2a-dda9af0a761c 61 fields · synced Jul 20, 2026