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Intraoral Archwire Thermo-Plus Medium - NiTi - 0, 53x0, 63mm (.021"x.025")
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50.72.228Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Intraoral Archwire Thermo-Plus Medium - NiTi - 0,53x0,63mm (.021"x.025") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Intraoral Archwire Thermo-Plus Medium - NiTi - 0,53x0,63mm (.021"x.025") FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED50.72.228 EUDAMEDFDA UDI
- Description
- Intraoral Archwire Thermo-Plus Medium - NiTi - 0,53x0,63mm (.021"x.025") FDA UDI
Identifiers
- Catalog Number
- 50.72.228 FDA UDI
- Primary DI / UDI-DI
- 07895742161378 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742161378 EUDAMED7895742172GB 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 Thermo-Plus Medium - NiTi - 0, 53x0, 63mm (.021"x.025") by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742161378 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742161378 | 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 9c3e3cb5-295f-4c09-8b07-8b4c22a57730 61 fields · synced Jul 31, 2026
- EUDAMED 4cae85b2-ccd4-45a8-b50e-79885429c60c 61 fields · synced May 19, 2026
- FDA UDI cd5a518d-0edc-44bd-b180-b7dc2c90570c 35 fields · synced May 29, 2026