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Dr. Max Helicobacter pylori test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 888017-1Model 800017-x
by PRIMA Lab SA
Identity
- Trade Name
- Dr. Max Helicobacter pylori test EUDAMED
- Device Name
- Dr. Max Helicobacter pylori Test EUDAMED
- Model / Reference
- 800017-x EUDAMED888017-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-888017SY EUDAMED
- Basic UDI-DI
- B-888017SY EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC 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
Yes
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
Dr. Max Helicobacter pylori 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-888017SY | 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 (1)
- EUDAMED 6be324a8-8b26-4f4c-8dd4-5c2b9099c326 61 fields · synced Jun 18, 2026