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BIOSYNEX Legionella pneumophila BSX

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532670100867
Basic UDI-DI: B-03532670100867
Reference: SW30002_BSX
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:37

Manufacturer products Authorised representative products Authorised representative actors View details

Group A streptococcus Rapid test Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-012124L3
Basic UDI-DI: B-012124L3
Reference: 012124-20-111
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Finland
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

Artron ONE STEP Tuberculosis Antibody (TB Ab) Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561383
Basic UDI-DI: B-00628347561383
Reference: A03-07-222
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter pylori (HP) Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561222
Basic UDI-DI: B-00628347561222
Reference: A02-11-422
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter Pylori (HP) Antibody Test

cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561178
Basic UDI-DI: B-00628347561178
Reference: A02-11-222
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561123
Basic UDI-DI: B-00628347561123
Reference: A02-09-322
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561116
Basic UDI-DI: B-00628347561116
Reference: A02-09-222
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561109
Basic UDI-DI: B-00628347561109
Reference: A02-09-213
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel® Ulcer (H. pylori) Screening Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059100518
Basic UDI-DI: B-00083059100518
Reference: 1005-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

LoopReagent

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Loop Diagnostics S.L.
Manufacturer SRN: ES-MF-000047379
UDI-DI: 08437024928010
Basic UDI-DI: 8437024928SL001R8B
Reference: SL001R
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

Manufacturer products View details

VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag

VRC005

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290883
Basic UDI-DI: 843661029VRC00501Q6
Reference: VRC005
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag

VRC004

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290876
Basic UDI-DI: 843661029VRC00401PZ
Reference: VRC004
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

VIRAPID® STREPTOCOCCUS GROUP A Ag

VRC003

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290869
Basic UDI-DI: 843661029VRC00301PU
Reference: VRC003
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Simple H.pyl-Tf

9.231.XXX.YY.ZZZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004679
Basic UDI-DI: 84295779231XW
Reference: 9.231.020.21.000
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:18

Manufacturer products View details

Simple / Stick Strep A

9.134.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004143
Basic UDI-DI: 84295779134XX
Reference: 9.134.040.00.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple GDH-Toxins

9.065.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003054
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.20.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

SIMPLE GDH / STICK GDH

9.045.XXX.YY.ZZZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002828
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.00.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Helori Urease

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169200644
Basic UDI-DI: 802816920BW01050503013Y
Reference: 1693
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:39

Manufacturer products View details

GenSure Strep A Rapid Test

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230364
Basic UDI-DI: 697683823P201900F9
Reference: P2019C01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

H.Pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250804
Basic UDI-DI: 6975156250000DZF
Reference: I021-N4002T-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details