Identity
- Trade Name
- Nitinol(NiTi) Orthodontic Springs EUDAMEDSmart FDA UDI
- Generic Name
- Orthodontic spring FDA UDI
- Device Name
- Nitinol Orthodontic Spring EUDAMEDNitinol(NiTi) Orthodontic Springs EUDAMED
- Model / Reference
- CS-10 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941784103379 EUDAMEDFDA UDI
- Basic UDI-DI
- 69417841NTCOILZ8 EUDAMEDB-06941784103379 EUDAMED
- FDA Product Code
- ECO FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic spring FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- France EUDAMEDItaly EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic retainer
Nitinol Orthodontic Spring by Beijing Smart Technology Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69417841NTCOILZ8 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69417841NTCOILZ8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Beijing Smart Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015988
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (3)
- EUDAMED 4aa73d2a-c5e8-4c43-a8aa-1ff6e7d332e2 61 fields · synced Jul 31, 2026
- EUDAMED a91f07b4-fa49-4842-8493-54bb3c690b81 61 fields · synced May 18, 2026
- FDA UDI a8e38acf-342f-40f8-b199-a8c59ea29f58 32 fields · synced May 30, 2026