Identity
- Trade Name
- SET OSSEOCARE PRO KM_102971 EUDAMED
- Device Name
- SET OSSEOCARE PRO KM_102971 EUDAMED
- Model / Reference
- 1700493-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- J00717004930011 EUDAMED
- Basic UDI-DI
- B-J00717004930011 EUDAMED
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Set Osseocare Pro Km_102971 by Bien-Air Dental SA — 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-J00717004930011 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
- EUDAMED SRN
- CH-MF-000014661
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (1)
- EUDAMED a6e267bd-6ead-4f22-a417-5fcb4d9b0754 61 fields · synced Jun 19, 2026