Identity
- Trade Name
- Nitinol(NiTi) Orthodontic Springs EUDAMED
- Device Name
- Nitinol(NiTi) Orthodontic Springs EUDAMEDNitinol Orthodontic Spring EUDAMED
- Model / Reference
- OS-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941784103409 EUDAMED
- Basic UDI-DI
- B-06941784103409 EUDAMED69417841NTCOILZ8 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Nitinol(NiTi) Orthodontic Springs by Beijing Smart Technology Co., 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-06941784103409 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06941784103409 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Smart Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015988
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 5c1c4de8-97f9-4f67-a541-e9aa83cf3171 61 fields · synced Aug 1, 2026
- EUDAMED c612e9ee-dd41-4e2c-9a01-5ee660f34e65 61 fields · synced May 18, 2026