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Ss Archwire Trueform I Upper 016x016 W/10
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 09.05.1066Model Archwires and Wires
Identity
- Trade Name
- SS ARCHWIRE TRUEFORM I UPPER 016X016 W/10 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- SS Archwire Trueform I Upper 016X016 w/10 FDA UDI
- Model / Reference
- Archwires and Wires EUDAMED09.05.1066 EUDAMEDFDA UDI
- Description
- SS Archwire Trueform I Upper 016X016 w/10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439261181 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439209JC EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ss Archwire Trueform I Upper 016x016 W/10 by Aditek do Brasil SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7899439209JC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED be37f493-a93f-4549-ac8b-d06066ee6c02 61 fields · synced Jun 18, 2026
- FDA UDI f8baf381-95e7-423f-bb33-b6668fa8a444 33 fields · synced May 30, 2026