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Prima Home Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 100077-1CSModel 100077-xRef 800062-1CSRef 800025-1CSModel 800025-xRef 800060-1Model 800060-xRef 800034-1CSModel 800034-xRef 100058-3CSModel 100058-x
by PRIMA Lab SA
Identity
- Trade Name
- PRIMA HOME TEST EUDAMED
- Device Name
- CELIAKIE TEST CELIAKIA TEST EUDAMEDHIV 1/2 SELF-TEST EUDAMEDŽELEZO FER TEST EUDAMEDSTREPTOKOK A TEST EUDAMEDCRP Test EUDAMEDINFEKCE MOČOVÝCH CEST TEST INFEKCIA MOČOVÝCH CIEST TEST EUDAMED
- Model / Reference
- 100077-x EUDAMED100077-1CS EUDAMED800062-1CS EUDAMED800025-x EUDAMED800025-1CS EUDAMED800060-x EUDAMED800060-1 EUDAMED800034-x EUDAMED800034-1CS EUDAMED100058-x EUDAMED100058-3CS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100077-1CSXZ EUDAMEDD-800062-1CS4B EUDAMEDD-800025-1CS3Q EUDAMEDD-800060-1CS3M EUDAMEDD-800034-1CS3S EUDAMEDD-100058-3CSXU EUDAMED
- Basic UDI-DI
- B-100077-1CSXZ EUDAMEDB-800062-1CS4B EUDAMEDB-800025-1CS3Q EUDAMEDB-800060-1CS3M EUDAMEDB-800034-1CS3S EUDAMEDB-100058-3CSXU EUDAMED
- EMDN Code
- W0102100699 CELIAC DISEASE - OTHER EUDAMEDW0105090302 HIV 1 / 2 - RT & POC EUDAMEDW0102070102 FERRITIN EUDAMEDW01021111 ANTI-STREPTOCOCCAL SCREENING EUDAMEDW0102019099 SPECIFIC PROTEINS - OTHER EUDAMEDW0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD Annex II List A EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Prima Home Test by PRIMA Lab SA — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-100077-1CSXZ | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (6)
- EUDAMED 8eae1017-25e6-411e-a6d9-a0d88480bced 61 fields · synced Sep 17, 2026
- EUDAMED 96787a50-4ceb-4d54-8ef0-3000c9d632ba 61 fields · synced May 16, 2026
- EUDAMED ea48fe06-d226-44e9-a133-8ef66fd9f2c0 61 fields · synced May 17, 2026
- EUDAMED 874442d6-616d-4e72-bbe9-ce5839cd49c8 61 fields · synced May 18, 2026
- EUDAMED b072455a-c640-4ca6-aa11-4ac5292a428b 61 fields · synced Jul 20, 2026
- EUDAMED 066435b9-a198-4b7e-8b94-0ee947019e39 61 fields · synced Aug 1, 2026