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71 device results listed.

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18906074569421

HPBELI-03

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074569421
Basic UDI-DI: B-18906074569421
Reference: HPBELI-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 18:20

Manufacturer products Authorised representative products Authorised representative actors View details

Merilyzer LumiQuant™ LQ100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459007056
Basic UDI-DI: 8905459LUMQDL
Reference: AALUQ-04
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

OvuFind

OVFRPD-01 OVFRPD-02

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006721
Basic UDI-DI: 8905459OVULHRDTSFA5
Reference: OVFRPD-01 OVFRPD-02
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

08905459006295

SAAEIQ-07

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006295
Basic UDI-DI: 8905459MERILEIAQUANTCJ
Reference: SAAEIQ-07
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Merilyzer AutoQuant 200 Excelus

FAACNQ-05

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459002426
Basic UDI-DI: 8905459FABA75
Reference: FAAAQ2-04
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

HIVFIND

HIVSST-01

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSterile

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001672
Basic UDI-DI: 8905459HIVOSF9V
Reference: HIVSST-01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

MEGRA Lyse -FDT

CLYCCR-03

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000859
Basic UDI-DI: 8905459BCLR8K
Reference: FDTCCR-03
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

MEGRA Diluent

BDTCCR-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000811
Basic UDI-DI: 8905459DILHEMRKCT
Reference: BDFCCR-03
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

MEGRA Detergent

DETCCR-04 DETCCR-05

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000798
Basic UDI-DI: 8905459DETHEMRKDX
Reference: DETCCR-06 DETCCR-07
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Merilyzer CelQuant Edge

Merilyzer CelQuant 360

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000736
Basic UDI-DI: 8905459HEMANA3K
Reference: HMTCLQ-15
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

08905459000224

MBTREK-01 MBTREK-02

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000224
Basic UDI-DI: 8905459RNAEXTAU
Reference: MBTREK-01 MBTREK-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI - 05

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074569438
Basic UDI-DI: B-18906074569438
Reference: HV4ELI - 05
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI - 09

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001665
Basic UDI-DI: B-08905459001665
Reference: HV4ELI - 09
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI – 08

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001269
Basic UDI-DI: B-08905459001269
Reference: HV4ELI – 08
EMDN: W0105030301
EMDN description: HIV P24 ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HPBELI-06

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001221
Basic UDI-DI: B-08905459001221
Reference: HPBELI-06
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HPBELI-07

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001238
Basic UDI-DI: B-08905459001238
Reference: HPBELI-07
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

08905459006929

RPDHBV-01 RPDHBV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006929
Basic UDI-DI: 8905459MHBSAGRTG4
Reference: RPDHBV-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/018 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08905459006912

RPDHCV-01 RPDHCV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006912
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-03
EMDN: W0105020308
EMDN description: HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08905459006738

OVFRPD-01 OVFRPD-02

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006738
Basic UDI-DI: 8905459OVULHRDTSFA5
Reference: OVFRPD-02
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

08905459006684

EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006684
Basic UDI-DI: 8905459HCGRTSF8Q
Reference: EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details