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SMD Dispenser
EUDAMEDClass I (EU MDR)
Ref 06.031.05.000.BLModel 06.031.03.000.JARef 06.031.05.000.NORef 06.031.09.000.JA
Identity
- Trade Name
- SMD Dispenser EUDAMED
- Device Name
- SMD Dispenser EUDAMED
- Model / Reference
- 06.031.03.000.JA EUDAMED06.031.05.000.BL EUDAMED06.031.05.000.NO EUDAMED06.031.09.000.JA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142423652 EUDAMED07640142423645 EUDAMED07640142423676 EUDAMED07640142426967 EUDAMED
- Basic UDI-DI
- 7640142410204009G 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 Dispenser 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 | 7640142410204009G | 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 (4)
- EUDAMED 268464c3-2fc6-461c-8a23-9fd01b00a45d 61 fields · synced Jul 30, 2026
- EUDAMED 3e1393fc-81b7-47b1-9dab-2b335244c146 61 fields · synced May 17, 2026
- EUDAMED 37a246d2-0293-4ea9-a6e7-fefd54a9fd6e 61 fields · synced May 17, 2026
- EUDAMED bb1a2480-6e27-4d0c-b780-36683b9810aa 61 fields · synced May 18, 2026