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Intraoral Archwire Superelastic Small - NiTi - Round Ø0, 35mm(.014")
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50.80.012Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Intraoral Archwire Superelastic Small - NiTi - Round Ø0,35mm(.014") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Intraoral Archwire Superelastic Small - NiTi - Round Ø0,35mm(.014") FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED50.80.012 EUDAMEDFDA UDI
- Description
- Intraoral Archwire Superelastic Small - NiTi - Round Ø0,35mm(.014") FDA UDI
Identifiers
- Catalog Number
- 50.80.012 FDA UDI
- Primary DI / UDI-DI
- 07895742058357 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742172GB EUDAMEDB-07895742058357 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal 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
Yes
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
No
FDA UDI
Intraoral Archwire Superelastic Small - NiTi - Round Ø0, 35mm(.014") by Dental Morelli Ltda. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7895742172GB | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742172GB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED 63948291-9ef2-411e-b401-2327a59c53ff 61 fields · synced Jun 18, 2026
- EUDAMED 3bdbdd2e-fd4d-45b5-99a5-1931e33596b3 61 fields · synced May 18, 2026
- FDA UDI 039268de-c601-46f1-9bf8-ce35db5fab44 35 fields · synced May 30, 2026