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ThermoBrite Slide Denaturation/ Hybridization System, S500-24

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002109
Basic UDI-DI: 849832026UX
Reference: 3800-004852-004
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

ThermoBrite Slide Denaturation/ Hybridization System, 120V

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002093
Basic UDI-DI: 849832026UX
Reference: 3800-004852-003
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Thermobrite

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002079
Basic UDI-DI: 849832026UX
Reference: 3800-004852-001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

ThermoBrite Slide Denaturation/ Hybridization System, S500-24

Thermobrite

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002086
Basic UDI-DI: 849832026UX
Reference: 3800-004852-002
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display Non-Connected

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657196
Basic UDI-DI: 0405686901935WA
Reference: 11702307
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Solution Display

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414640778
Basic UDI-DI: 0405686901935WA
Reference: 11645015
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Solution Display

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414640785
Basic UDI-DI: 0405686901935WA
Reference: 11645018
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System (4-Channel)

G2MRAPI4001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200087
Basic UDI-DI: 890617820G2MRAPI4001CV
Reference: G2MRAPI4001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System-(6-Channel)

G2MRAPI4002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200094
Basic UDI-DI: 890617820G2MRAPI4002CX
Reference: G2MRAPI4002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi-X 96 Automated Nucleic Acid Extraction System

G2MI80001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200100
Basic UDI-DI: 890617820G2MI80001QZ
Reference: G2MI80001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi-X 16 Automated Nucleic Acid Extraction System

G2MI80002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200117
Basic UDI-DI: 890617820G2MI80002R3
Reference: G2MI80002
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

One PCR Ultra-Fast RT PCR System

IG2M5001UF

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200162
Basic UDI-DI: 890617820IG2M5001UF9L
Reference: IG2M5001UF
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi Q- Micro RT PCR System

IG2M5001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200698
Basic UDI-DI: 890617820IG2M5001KQ
Reference: IG2M5001
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapi Q HT - Micro RT PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200704
Basic UDI-DI: 890617820IG2M5001KQ
Reference: IG2M5001HT
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Manta

Manta Automated Sample Prep Robot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: CAMBRIAN BIOTECH PRIVATE LIMITED
Manufacturer SRN: IN-MF-000046319
UDI-DI: 08906193750000
Basic UDI-DI: 890619375CBWM100-CAL
Reference: CBWM100-C
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Spain
Authorised representative: Specculo Limited
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed 3 Part Haematology Analyser

LM001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470006
Basic UDI-DI: 890619447LM001EX
Reference: LM001
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed Urine Analyser

LM006

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470051
Basic UDI-DI: 890619447LM006F9
Reference: LM006
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed CLIA Reader

LM007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470068
Basic UDI-DI: 890619447LM007FB
Reference: LM007
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

BLOTrix System 4/ BLOTrix Reader S1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270584
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrs1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:30

Manufacturer products View details

BLOTrix System 4/ BLOTrix Reader C1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270553
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrc1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:28

Manufacturer products View details