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XP-endo Shaper
EUDAMEDClass IIa (EU MDR)
Ref S1.XB0.00.0AK.FKRef S1.XB0.00.SAC.FK
Identity
- Trade Name
- XP-endo Shaper EUDAMEDXP-endo Shaper Plus Sequence EUDAMED
- Device Name
- XP-endo Shaper EUDAMEDXP-endo Shaper Plus Sequence EUDAMED
- Model / Reference
- S1.XB0.00.0AK.FK EUDAMEDS1.XB0.00.SAC.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142414186 EUDAMED07640142414483 EUDAMED
- Basic UDI-DI
- B-07640142414186 EUDAMEDB-07640142414483 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
XP-endo Shaper by FKG Dentaire Sàrl — 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-07640142414186 | 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 b6d3793b-df41-4371-adac-e477ccd2b456 61 fields · synced Jul 20, 2026
- EUDAMED d998dc09-f9fa-45fb-9b17-7cf38da24a0e 61 fields · synced May 18, 2026