Identity
- Trade Name
- BT-Apisafe EUDAMED
- Device Name
- BT-Apisafe EUDAMED
- Model / Reference
- S1.6B0.00.0AA.FK EUDAMEDS1.6B0.00.0AD.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142413516 EUDAMED07640142413554 EUDAMED
- Basic UDI-DI
- B-07640142413516 EUDAMEDB-07640142413554 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Manual endodontic file/rasp, reusable
BT-Apisafe by FKG Dentaire Sàrl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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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-07640142413516 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FKG Dentaire Sàrl
- EUDAMED SRN
- CH-MF-000017925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ffc00711-3856-4fa1-ac94-c96572da6bd8 61 fields · synced Aug 1, 2026
- EUDAMED aeecdcc1-bffb-4a41-b9b5-28df99d2bb68 61 fields · synced May 18, 2026