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Orthodontic Elastomeric Accessories
EUDAMEDClass IIa (EU MDR)
Ref 91B3-01AModel Elastic drag ring
Identity
- Trade Name
- Orthodontic Elastomeric Accessories EUDAMED
- Device Name
- Orthodontic Elastomeric Auxiliaries EUDAMED
- Model / Reference
- Elastic drag ring EUDAMED91B3-01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054766393 EUDAMED
- Basic UDI-DI
- 697039438100KG EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS 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 retainer
Orthodontic Elastomeric Accessories by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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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 | 697039438100KG | 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 bb5e7fe7-8b7c-4b7e-bf46-c054af516c87 61 fields · synced Oct 5, 2026