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Wire TMA TiMo - Round Ø0, 45mm (.018") Stick
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 56.01.004Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Wire TMA TiMo - Round Ø0,45mm (.018") Stick EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- Wire TMA TiMo - Round Ø0,45mm (.018") Stick FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED56.01.004 EUDAMEDFDA UDI
- Description
- Wire TMA TiMo - Round Ø0,45mm (.018") Stick FDA UDI
Identifiers
- Catalog Number
- 56.01.004 FDA UDI
- Primary DI / UDI-DI
- 07895742077822 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742077822 EUDAMED7895742172GB 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, 45mm (.018") Stick by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07895742077822 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742077822 | 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 92ac209e-d04f-4c63-887c-e6d567901d8d 61 fields · synced Jun 18, 2026
- EUDAMED 5b3b79a3-c69d-4ef3-901f-e3ed35e3479a 61 fields · synced May 19, 2026
- FDA UDI 5d01300c-d773-4d3e-9e9e-80e0f70bd6c5 36 fields · synced May 30, 2026