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Name: Spektra Model: Nickel Titanium arches
EUDAMEDClass IIa (EU MDR)
Ref ASCE16UModel Nickel Titanium
Identity
- Device Name
- Name: Spektra Model: Nickel Titanium arches EUDAMED
- Model / Reference
- Nickel Titanium EUDAMEDASCE16U EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICASCE16U1 EUDAMED
- Basic UDI-DI
- ++EMICFAM3A1ANTHC EUDAMED
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
The Spektra Model is a high-performance, nickel-titanium arch device designed for endocrine disruptor assessment. It features advanced self-testing capabilities and is classified as a Class IIa medical instrument.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EMICFAM3A1ANTHC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED 9ac40689-a095-44ea-9896-c8a1a1fd667f 61 fields · synced Jul 12, 2026