Identity
- Trade Name
- ClearNote EUDAMED
- Device Name
- ClearNote Health Specimen Collection Kit EUDAMED
- Model / Reference
- CN4201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061041770005 EUDAMED
- Basic UDI-DI
- 506104177CN4201NP EUDAMED
- EMDN Code
- W050101010202 BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal 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
ClearNote by Roylance Scientific LTD — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506104177CN4201NP | Class A | No Longer Active |
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Manufacturer
- Manufacturer
- Roylance Scientific LTD
- EUDAMED SRN
- UK-MF-000040266
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 1489f92e-3a38-4242-b201-8afd6def1baa 61 fields · synced Jul 21, 2026