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Intraoral Archwire Superelastic Large STD NiTi - Round Ø0, 30mm (.012")
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50.60.011Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Intraoral Archwire Superelastic Large STD NiTi - Round Ø0,30mm (.012") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Intraoral Archwire Superelastic Large STD NiTi - Round Ø0,30mm (.012") FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED50.60.011 EUDAMEDFDA UDI
- Description
- Intraoral Archwire Superelastic Large STD NiTi - Round Ø0,30mm (.012") FDA UDI
Identifiers
- Catalog Number
- 50.60.011 FDA UDI
- Primary DI / UDI-DI
- 07895742000035 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742172GB EUDAMEDB-07895742000035 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 Large STD NiTi - Round Ø0, 30mm (.012") 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 c8db8b64-f75f-4b10-922b-cd1054d8f164 61 fields · synced Aug 1, 2026
- EUDAMED 33d6ea31-90f7-4e8f-9419-f7864e4e4c09 61 fields · synced May 18, 2026
- FDA UDI a1b43f56-4e3e-4b18-a07c-8e8666b55a2f 35 fields · synced May 30, 2026