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Self-ligating Brackets
EUDAMEDClass IIa (EU MDR)
Ref 83N1-23E-A4Model Self-ligating
Identity
- Trade Name
- Self-ligating Brackets EUDAMED
- Device Name
- Brackets EUDAMED
- Model / Reference
- Self-ligating EUDAMED83N1-23E-A4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054766881 EUDAMED
- Basic UDI-DI
- 697039438001KD EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Orthodontic tube
Self-ligating Brackets by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697039438001KD | Class IIa | 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 22a62a11-956b-4717-959b-0435567fb64f 61 fields · synced Jul 9, 2026