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Name: Spinnaker Model: Direct Bonding Stainless Steel Orthodontic buccal tubes
EUDAMEDClass IIa (EU MDR)
Ref TLSR2C46Model Direct buccal tubes
Identity
- Device Name
- Name: Spinnaker Model: Direct Bonding Stainless Steel Orthodontic buccal tubes EUDAMED
- Model / Reference
- Direct buccal tubes EUDAMEDTLSR2C46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICTLSR2C461 EUDAMED
- Basic UDI-DI
- ++EMICFAM3C4DD5K EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER 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
Name: Spinnaker Model: Direct Bonding Stainless Steel Orthodontic buccal tubes by Micerium S.p.A. — Class IIa — MDR — listed in EUDAMED
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 | ++EMICFAM3C4DD5K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED 6095466c-4485-474c-8dea-ccb56e5fccde 61 fields · synced Aug 5, 2026