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STREPTEX RAPID

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501390
Basic UDI-DI: 50560805StreptexAcidL5
Reference: R30950555
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501376
Basic UDI-DI: 50560805StreptexU9
Reference: R30950501
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING UNIVERSAL KIT

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501352
Basic UDI-DI: 50560805PathDXStrepC7
Reference: R62076
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX EXTRACTION REAGENT 1

PATHODX EXTRACTION REAGENT

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501307
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62050
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501291
Basic UDI-DI: 50560805PathoDXReagPCQV
Reference: R24042
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP A GROUPING LATEX

PATHODX STREP GROUPING LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501246
Basic UDI-DI: 50560805PathoDXLatex3G
Reference: R62030
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501239
Basic UDI-DI: 50560805PathoDXStrep98
Reference: R62025
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.TB

TB.300

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000018
Basic UDI-DI: 5051716TBRB
Reference: TB.300
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Safety summary (SSCP/SSP): TD-TB-01 SSP-01 · Rev. R1
Authorised representative: Wallac Oy
Last updated: 31.07.2026 08:06

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

PATHFAST TB LAM Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301162
Basic UDI-DI: 4987595PF1231KXJ
Reference: 30116
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ MTBC Detection Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145191377
Basic UDI-DI: 4987026TD-LFTBZE
Reference: 972000
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 31.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395280

TRCR MB-Lysis Reagent

IVD Class AIVDR 2017/746No longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395280
Basic UDI-DI: 456018921000200273
Reference: 0056202
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

04250592378582

eazyplex® hv-K.pneumoniae

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: AmplexDiagnostics GmbH
Manufacturer SRN: DE-MF-000014117
UDI-DI: 04250592378582
Basic UDI-DI: 42505923HVKPN8
Reference: 7858
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:42

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527332
Basic UDI-DI: 868521452PCR172GD
Reference: LYO172WS24
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:56

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527370
Basic UDI-DI: 868521452PCR172GD
Reference: LYO172WS96
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:56

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035818
Basic UDI-DI: 868521452PCR172GD
Reference: CFP172P50
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:56

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035825
Basic UDI-DI: 868521452PCR172GD
Reference: CFP172P100
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:56

Manufacturer products View details

VIDAS® TB-IGRA

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608576
Basic UDI-DI: 357302BUDI000853U7
Reference: 423111
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

Manufacturer products View details

Lyophilized rabbit plasma

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026584061
Basic UDI-DI: 357302BUDI000489U8
Reference: 540602
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

VIDAS® C. difficile GDH

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026334819
Basic UDI-DI: 357302BUDI000588UB
Reference: 30125
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

VIDAS® Lyme IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026265083
Basic UDI-DI: 357302BUDI000084TA
Reference: 30319
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details