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Arco Niti Thermo M .012u Pc C/10
EUDAMEDClass IIa (EU MDR)
Ref 39301-12012Model Arcos e Fios de Nitinol
Identity
- Trade Name
- ARCO NITI THERMO M .012U PC C/10 EUDAMED
- Device Name
- Orthodontic Wire Nitinol EUDAMED
- Model / Reference
- Arcos e Fios de Nitinol EUDAMED39301-12012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908610031748 EUDAMED
- Basic UDI-DI
- B-07908610031748 EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Arco Niti Thermo M .012u Pc C/10 by Id-Logical Industria E Comercio Ltda — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07908610031748 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Id-Logical Industria E Comercio Ltda
- EUDAMED SRN
- BR-MF-000034402
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (1)
- EUDAMED 634e88b5-91b4-4038-9b67-9add6a6515a0 61 fields · synced Sep 18, 2026