Identity
- Device Name
- SH24 STI Rectal Sample Collection Kit EUDAMED
- Model / Reference
- Indigo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065024320379 EUDAMED
- Basic UDI-DI
- 5065024320RectalMM EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
SH24 STI Rectal Sample Collection Kit by SH24 Digital 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 | 5065024320RectalMM | Class A | Active |
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Manufacturer
- Manufacturer
- SH24 Digital Ltd
- EUDAMED SRN
- UK-MF-000048864
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED ebdfdfa6-27da-42d5-92b2-ac4fe1ea0b8f 61 fields · synced Jun 17, 2026