← Back to catalogue
GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal
EUDAMEDClass IVD General (EU MDR)
Ref G2M803621,G2M803621RModel G2M803621
Identity
- Trade Name
- GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal EUDAMED
- Device Name
- GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal EUDAMED
- Model / Reference
- G2M803621 EUDAMEDG2M803621,G2M803621R EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G2M803621FT EUDAMED
- Basic UDI-DI
- B-G2M803621FT EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal by Genes 2Me Private Limited — Class IVD General — IVDD — listed in EUDAMED
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-G2M803621FT | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genes 2Me Private Limited
- EUDAMED SRN
- IN-MF-000035953
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 441b4ed9-77b4-4d11-94fd-a71e7a874ab6 61 fields · synced Oct 6, 2026
- EUDAMED 441b4ed9-77b4-4d11-94fd-a71e7a874ab6-1 61 fields · synced Jun 10, 2026