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LetsGetChecked Blood and Urine Home Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref BU02I and BU02URef BO20IRef BO27IRef BO06IRef BU02I Ref BO28I
Identity
- Trade Name
- LetsGetChecked Blood and Urine Home Sample Collection Kit EUDAMEDLetsGetChecked Blood Home Sample Collection Kit EUDAMED
- Device Name
- Blood and Urine Home Sample Collection Kit EUDAMEDLetsGetChecked Blood Home Sample Collection Kit EUDAMEDLetsGetChecked Blood and Urine Home Sample Collection Kit EUDAMED
- Model / Reference
- BU02I and BU02U EUDAMEDBO20I EUDAMEDBO27I EUDAMEDBO06I EUDAMEDBU02I EUDAMEDBO28I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810111410823 EUDAMED00850024881297 EUDAMED00850024881457 EUDAMED00850024881044 EUDAMED00850024881440 EUDAMED
- Basic UDI-DI
- 081011141BUHC EUDAMED850024881BOSB EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMEDW0501010299 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
Yes
EUDAMEDEUDAMED
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 and Urine 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 | 081011141BUHC | Class A | Active |
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Manufacturer
- Manufacturer
- PrivaPath Diagnostics Limited
- EUDAMED SRN
- IE-MF-000045162
Sources (6)
- EUDAMED 41651040-b8b8-47a9-9cee-9e23b5d6c06a 61 fields · synced Jul 22, 2026
- EUDAMED a8c7244b-e1f0-49b2-942a-af8a8a11e3a4 61 fields · synced Jul 15, 2026
- EUDAMED 11a40064-65c1-440e-be36-3b11d826d7b9 61 fields · synced Jul 15, 2026
- EUDAMED 9d073cb4-2839-444b-81a3-f119565421dd 61 fields · synced Jul 16, 2026
- EUDAMED 5e61bd99-2463-4f35-9b9f-5e25c3453c22 61 fields · synced Jul 19, 2026
- EUDAMED 05ccba6c-95bd-4c06-b311-8c55fb793f00 61 fields · synced Jul 22, 2026