Identity
- Trade Name
- Titan BioStar ˚5 EUDAMED
- Device Name
- Titan BioStar ˚5 8mm EUDAMED
- Model / Reference
- SD136508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260580283187 EUDAMED
- Basic UDI-DI
- B-04260580283187 EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Titan BioStar ˚5 by Scheftner GmbH — 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-04260580283187 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scheftner GmbH
- EUDAMED SRN
- DE-MF-000049419
Sources (1)
- EUDAMED 35c3dce7-75d0-45d4-b44b-027fe2bb2352 61 fields · synced Jun 18, 2026