Identity
- Trade Name
- ClearPrep EUDAMED
- Device Name
- Clear Prep Cytology System EUDAMED
- Model / Reference
- CP11006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850046768002 EUDAMED
- Basic UDI-DI
- 0850046768CPBS EUDAMED
- EMDN Code
- W05020199,W05039099 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ClearPrep by Resolution Biomedical, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850046768CPBS | Class A | Active |
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Manufacturer
- Manufacturer
- Resolution Biomedical, Inc.
- EUDAMED SRN
- US-MF-000029623
- Authorised Representative
- Cost Saving Solutions Europe Ltd IE-AR-000016085
Sources (1)
- EUDAMED 512e2f04-ee02-404e-bb95-90c4ca8fee37 61 fields · synced Jun 18, 2026