Identity
- Trade Name
- Confident® Fit 50 ml EUDAMED
- Device Name
- Kit Confident® Fit 50 ml EUDAMED
- Model / Reference
- CK-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770026787021 EUDAMED
- Basic UDI-DI
- 3770026787FitD9 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Confident® Fit 50 ml by Pk21-5 — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3770026787FitD9 | Class I | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pk21-5
- EUDAMED SRN
- FR-MF-000026817
Sources (1)
- EUDAMED c1945f61-aa33-4f04-bb2d-e0aeac4f97ee 61 fields · synced Jul 9, 2026