Identity
- Trade Name
- One PCR Ultra-Fast RT PCR System EUDAMED
- Device Name
- One PCR Ultra-Fast RT PCR System EUDAMED
- Model / Reference
- IG2M5001UF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906178200162 EUDAMED
- Basic UDI-DI
- 890617820IG2M5001UF9L EUDAMED
- Direct Marketing DI
- 08906178200162 EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
One PCR Ultra-Fast RT PCR System by Genes 2Me Private Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 890617820IG2M5001UF9L | Class A | Active |
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Manufacturer
- Manufacturer
- Genes 2Me Private Limited
- EUDAMED SRN
- IN-MF-000035953
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fe6d7b24-a0be-48a2-a139-7289028a1881 61 fields · synced Aug 2, 2026