Identity
- Device Name
- Saliva Sample Collection Kit EUDAMED
- Model / Reference
- KSL-COR-ACT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060627580625 EUDAMED
- Basic UDI-DI
- 5060625758KSL6Q EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva Sample Collection Kit by Medichecks.com LTD — 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 | 5060625758KSL6Q | Class A | Active |
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Manufacturer
- Manufacturer
- Medichecks.com LTD
- EUDAMED SRN
- GB-MF-000024123
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 52156247-acfe-4bb8-a241-d7760429c34c 61 fields · synced Jul 12, 2026