← Back to catalogue
PML-RARA Real-Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref G2M708821,G2M708821RModel G2M708821
Identity
- Trade Name
- PML-RARA Real-Time PCR Kit EUDAMED
- Device Name
- PML-RARA Real-Time PCR Kit EUDAMED
- Model / Reference
- G2M708821 EUDAMEDG2M708821,G2M708821R EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G2M708821GT EUDAMED
- Basic UDI-DI
- B-G2M708821GT EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER 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
The PML-RARA Real-Time PCR Kit is a cutting-edge medical device designed for real-time PCR (Polymerase Chain Reaction) analysis, providing reliable and accurate results in various diagnostic applications. The device features advanced technology, robust performance, and ease of use, making it an ideal choice for healthcare professionals and researchers.
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-G2M708821GT | 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 8f598d10-94b1-46de-a5be-0bf280d2fa08 61 fields · synced Jul 20, 2026
- EUDAMED 8f598d10-94b1-46de-a5be-0bf280d2fa08-1 61 fields · synced Jun 9, 2026