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Wire TMA TiMo - Round Ø0, 35mm (.014") Stick
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 56.01.002Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Wire TMA TiMo - Round Ø0,35mm (.014") Stick EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- Wire TMA TiMo - Round Ø0,35mm (.014") Stick FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED56.01.002 EUDAMEDFDA UDI
- Description
- Wire TMA TiMo - Round Ø0,35mm (.014") Stick FDA UDI
Identifiers
- Catalog Number
- 56.01.002 FDA UDI
- Primary DI / UDI-DI
- 07895742077808 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742172GB EUDAMEDB-07895742077808 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
- Portugal EUDAMED
- Commercial Distribution
- Not 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
Wire TMA TiMo - Round Ø0, 35mm (.014") Stick 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 bfbd7c4a-0b87-463b-be44-072b31af051d 61 fields · synced Jul 27, 2026
- EUDAMED fc54f2c0-0e6a-450f-8dfc-2c80fc390360 61 fields · synced May 17, 2026
- FDA UDI d59c7835-ab05-4e5f-88d6-f498c28a3707 36 fields · synced May 30, 2026