Identity
- Trade Name
- FlexiWedge Large Purple Refill EUDAMED
- Device Name
- FlexiWedge Kit EUDAMED
- Model / Reference
- KW100 EUDAMEDFW05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850020204052 EUDAMED
- Basic UDI-DI
- 0850020204flexiwedgeY2 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
FlexiWedge Large Purple Refill by Common Sense Dental Products — 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 | 0850020204flexiwedgeY2 | Class I | Active |
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Manufacturer
- Manufacturer
- Common Sense Dental Products
- EUDAMED SRN
- US-MF-000009859
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 286d7379-bb85-4458-ab2d-271ba89cda2f 61 fields · synced Jun 18, 2026