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Meril RNA Extraction Kit (Magnetic beads)
EUDAMEDClass A (EU MDR)
Ref MBTREK-07 MBTREK-08 MBTREK-09Model MBTREK-01 MBTREK-02
Identity
- Device Name
- Meril RNA Extraction Kit (Magnetic beads) EUDAMED
- Model / Reference
- MBTREK-01 MBTREK-02 EUDAMEDMBTREK-07 MBTREK-08 MBTREK-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905459001337 EUDAMED
- Basic UDI-DI
- 8905459RNAEXTAU EUDAMED
- Direct Marketing DI
- 08905459001337 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Meril RNA Extraction Kit (Magnetic beads) by Meril Diagnostics Pvt. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 8905459RNAEXTAU | Class A | Active |
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Manufacturer
- Manufacturer
- Meril Diagnostics Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000028158
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED eb29feaf-9f3e-4a74-b9d1-4222e272a50a 61 fields · synced Jul 31, 2026