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Wires
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 57.47.4000
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC ARCHWIRES SEQUENCE FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Wires EUDAMEDSEQUENCE OF ARCHWIRES KIT FOR SELF LIGATING BRACKETS FDA UDI
- Model / Reference
- 57.47.4000 EUDAMEDFDA UDI
- Description
- SEQUENCE OF ARCHWIRES KIT FOR SELF LIGATING BRACKETS FDA UDI
Identifiers
- Catalog Number
- 57.47.4000 FDA UDI
- Primary DI / UDI-DI
- 07898488901239 EUDAMEDFDA UDI
- Basic UDI-DI
- 789848890WIRES8X 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
Yes
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
Wires by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 789848890WIRES8X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED e65be0e8-680e-4555-9669-45740df82f0a 61 fields · synced May 30, 2026
- FDA UDI d76b3bd6-b14a-4d44-8bfc-f017ff2c1fa6 34 fields · synced May 30, 2026