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LetsGetChecked Blood Home Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref BO08I
Identity
- Trade Name
- LetsGetChecked Blood Home Sample Collection Kit EUDAMED
- Device Name
- LetsGetChecked Blood Home Sample Collection Kit EUDAMED
- Model / Reference
- BO08I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860003211212 EUDAMED
- Basic UDI-DI
- 8600032112BO86 EUDAMED
- EMDN Code
- W0501010299 CAPILLARY BLOOD 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
LetsGetChecked Blood Home Sample Collection Kit by Privapath Diagnostics 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 | 8600032112BO86 | Class A | Active |
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Manufacturer
- Manufacturer
- PrivaPath Diagnostics Limited
- EUDAMED SRN
- IE-MF-000045162
Sources (1)
- EUDAMED 2acd2d49-06a8-441f-88e9-7daecf178ae7 61 fields · synced Jun 18, 2026