Identity
- Device Name
- CBL400 EUDAMED
- Model / Reference
- PQ069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EFSMPQ0690 EUDAMED
- Basic UDI-DI
- ++EFSMCBL400XS EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Cbl400 by First Scientific Dental Materials GmbH — Class IIa — 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 | ++EFSMCBL400XS | Class IIa | Active |
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Manufacturer
- Manufacturer
- First Scientific Dental Materials GmbH
- EUDAMED SRN
- DE-MF-000005436
Sources (1)
- EUDAMED 28b07c65-b2da-4c87-a13f-44999ab5d63e 61 fields · synced Aug 4, 2026