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GA-map® COVID-19 Fecal Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref 1010Model GA-map® COVID-19 Fecal Test Kit
Identity
- Trade Name
- GA-map® COVID-19 Fecal Test Kit EUDAMED
- Device Name
- GA-map® COVID-19 Fecal Test Kit EUDAMED
- Model / Reference
- GA-map® COVID-19 Fecal Test Kit EUDAMED1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-101099 EUDAMED
- Basic UDI-DI
- B-101099 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GA-map® COVID-19 Fecal Test Kit by Genetic Analysis AS — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: The GA-map® COVID-19 Fecal Test Kit
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-101099 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genetic Analysis AS
- EUDAMED SRN
- NO-MF-000023768
Sources (1)
- EUDAMED b08807d3-3596-42df-b914-c65363244449 61 fields · synced Jun 19, 2026