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Dr.Max+
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 880034-1Model 800034-x
by PRIMA Lab SA
Identity
- Trade Name
- Dr.Max+ EUDAMEDCRP Test EUDAMED
- Device Name
- CRP Test EUDAMED
- Model / Reference
- 880034-1 EUDAMED800034-x EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-880034R8 EUDAMED
- Basic UDI-DI
- B-880034R8 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Dr.Max+ 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-880034R8 | 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 (2)
- EUDAMED 7fe16a6c-12e8-4caf-b5c8-6f5bc5afc74d 61 fields · synced Jun 18, 2026
- EUDAMED b659dedf-adc4-41ed-8ee8-c86ea07aa4b2 61 fields · synced Jun 11, 2026