Identity
- Device Name
- Bands EUDAMED
- Model / Reference
- Plain Bands EUDAMED5001-000-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970394385905 EUDAMED
- Basic UDI-DI
- 697039438105KS EUDAMED
- EMDN Code
- Q010402 ORTHODONTIC BANDS 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
Bands by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697039438105KS | 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 8a0f64a9-ea69-4795-ade3-80eaed2b6d52 61 fields · synced Jun 18, 2026