Identity
- Device Name
- Nitinol Orthodontic Spring EUDAMED
- Model / Reference
- OS-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941784104352 EUDAMED
- Basic UDI-DI
- 69417841NTCOILZ8 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Orthodontic Spring by Beijing Smart Technology Co., Ltd. — Class IIa — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69417841NTCOILZ8 | 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 (1)
- EUDAMED 6dd648f6-d92a-4ad6-b517-1a85699b25e3 61 fields · synced Jun 17, 2026