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brackets
EUDAMEDClass IIa (EU MDR)
Ref 8315-25BModel MBT* bracketsRef 10005844Model Edgewise BracketsRef 8116-10B
Identity
- Device Name
- brackets EUDAMED
- Model / Reference
- MBT* brackets EUDAMED8315-25B EUDAMEDEdgewise Brackets EUDAMED10005844 EUDAMED8116-10B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054773001 EUDAMEDD-1086R EUDAMED06942054733388 EUDAMED
- Basic UDI-DI
- B-06942054773001 EUDAMEDB-1086R EUDAMED694205470001DT 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
EUDAMEDEUDAMED
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
brackets by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDR, 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06942054773001 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06942054773001 | 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 (3)
- EUDAMED e9b281ad-c2c6-4f6d-ad8e-30e15a3cc6f7 61 fields · synced Oct 6, 2026
- EUDAMED c7e62a1f-cc4a-4297-835e-f126091de453 61 fields · synced May 18, 2026
- EUDAMED c969890a-5402-49c5-99a0-944282882dcd 61 fields · synced May 19, 2026