Identity
- Device Name
- bracket EUDAMED
- Model / Reference
- Roth brackets EUDAMED82FA-20C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054772554 EUDAMED
- Basic UDI-DI
- B-06942054772554 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
bracket by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942054772554 | 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 9ca495db-217d-4434-9296-593dc15d4a2e 61 fields · synced Oct 6, 2026