Identity
- Trade Name
- Home Saliva Collection Kit EUDAMED
- Device Name
- Home Saliva Collection Kit EUDAMED
- Model / Reference
- SCK10654 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273219333 EUDAMED
- Basic UDI-DI
- 50552732AHSSCKT056NR 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
Home Saliva Collection Kit by Randox Laboratories Limited — 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 | 50552732AHSSCKT056NR | Class A | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 3faa5b81-0edc-4982-ad24-0525de4f75e2 61 fields · synced Jun 19, 2026