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Lingual Buttons
EUDAMEDClass IIa (EU MDR)
Ref 1-2A2Model Lingual buttonRef 9131-2A1
Identity
- Trade Name
- Lingual Buttons EUDAMED
- Device Name
- Lingual Buttons EUDAMED
- Model / Reference
- Lingual button EUDAMED1-2A2 EUDAMED9131-2A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1216H EUDAMED06970394382621 EUDAMED
- Basic UDI-DI
- B-1216H EUDAMED697039438101KJ EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMEDNetherlands 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
Lingual Buttons by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-1216H | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-1216H | 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 (2)
- EUDAMED 39152c4b-24cd-4e80-a2ea-81f76dd926a5 61 fields · synced Jul 9, 2026
- EUDAMED 4b751e39-3535-45d3-8a90-0a39d169a58d 61 fields · synced May 19, 2026