← Back to catalogue
GA-map® Dysbiosis Test Lx v2
EUDAMEDClass IVD General (EU MDR)
Ref 1001Model GA-map® Dysbiosis Test Lx v2
Identity
- Trade Name
- GA-map® Dysbiosis Test Lx v2 EUDAMED
- Device Name
- GA-map® Dysbiosis Test Lx v2 EUDAMED
- Model / Reference
- GA-map® Dysbiosis Test Lx v2 EUDAMED1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01001DP EUDAMED
- Basic UDI-DI
- B-01001DP EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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® Dysbiosis Test Lx v2 by Genetic Analysis AS — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: The GA-map® Dysbiosis Test Lx
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-01001DP | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genetic Analysis AS
- EUDAMED SRN
- NO-MF-000023768
Sources (1)
- EUDAMED bea7a9ae-5503-4731-894c-85c343b5f664 61 fields · synced Jul 10, 2026