← Back to catalogue
Stainless Steel Wire Ligature for Tie (Amarrilho)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 55.14.0008
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC SS - WIRE FOR LIGATURE FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Stainless Steel Wire Ligature for Tie (Amarrilho) EUDAMEDSS WIRES FOR LIGATURE 0.08" - (0,20MM)- 40G FDA UDI
- Model / Reference
- 55.14.0008 EUDAMEDFDA UDI
- Description
- SS WIRES FOR LIGATURE 0.08" - (0,20MM)- 40G FDA UDI
Identifiers
- Catalog Number
- 55.14.0008 FDA UDI
- Primary DI / UDI-DI
- 07898488903714 EUDAMEDFDA UDI
- Basic UDI-DI
- 789848890LIGATURE2Y EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010406 ORTHODONTIC LIGATURES 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
Stainless Steel Wire Ligature for Tie (Amarrilho) by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI…
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 | 789848890LIGATURE2Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED 84856a7f-953e-45ee-b822-a6a5040857f3 61 fields · synced Jun 18, 2026
- FDA UDI e2723c86-17d1-46fa-85aa-6d31f2ae091a 34 fields · synced May 30, 2026