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Bands
EUDAMEDClass IIa (EU MDR)
Ref E52C1-24J-117Model 1st Moral BandsRef 10005844Model Plain Bands
Identity
- Device Name
- Bands EUDAMED
- Model / Reference
- 1st Moral Bands EUDAMEDE52C1-24J-117 EUDAMEDPlain Bands EUDAMED10005844 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1156N EUDAMEDD-10519P EUDAMED
- Basic UDI-DI
- B-1156N EUDAMEDB-10519P EUDAMED
- EMDN Code
- Q010402 ORTHODONTIC BANDS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMEDNetherlands 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
Bands by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-1156N | 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 60b3e921-5558-4b97-a83d-c1efa9ab36cf 61 fields · synced Jul 9, 2026
- EUDAMED 215022de-47a5-4acf-a4dd-bdbb654f3204 61 fields · synced May 19, 2026