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Smd
EUDAMEDClass I (EU MDR)
Ref 06.030.09.100.JAModel 06.030.03.010.TRRef 06.030.09.100.TRRef 06.030.05.010.TRRef 06.030.05.100.JARef 06.030.09.051.BLRef 06.030.09.010.TR
Identity
- Trade Name
- SMD EUDAMED
- Device Name
- SMD EUDAMED
- Model / Reference
- 06.030.03.010.TR EUDAMED06.030.09.100.JA EUDAMED06.030.09.100.TR EUDAMED06.030.05.010.TR EUDAMED06.030.05.100.JA EUDAMED06.030.09.051.BL EUDAMED06.030.09.010.TR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142423621 EUDAMED07640142423638 EUDAMED07640142423539 EUDAMED07640142423553 EUDAMED07640142423607 EUDAMED07640142426943 EUDAMED
- Basic UDI-DI
- 7640142410203009B EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Smd by FKG Dentaire Sàrl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7640142410203009B | Class I | 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 (6)
- EUDAMED 9c728bee-54ce-470e-88d1-2865d1d435fc 61 fields · synced Sep 18, 2026
- EUDAMED 30ca77e5-ce93-465e-8b25-8e7ca3bd82c7 61 fields · synced May 16, 2026
- EUDAMED ba648640-8797-46d7-951e-e1e76796719a 61 fields · synced May 17, 2026
- EUDAMED 4ae78191-cb13-4352-99fa-f37a05c95808 61 fields · synced May 17, 2026
- EUDAMED e55d0792-87f2-4359-b466-d6f09520fc99 61 fields · synced May 17, 2026
- EUDAMED b2cc7d7e-afeb-4edb-942f-4f2460e18195 61 fields · synced May 17, 2026