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Acmex Treponema Pallidum (TP) Antibody Test

Cassette

IVD Class CIVDR 2017/746On the marketKitNear-patient testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561093
Basic UDI-DI: 62834756AL02090279
Reference: AM02-09-322P
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-TP Ab(WB)-2024 · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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

05902643958944

RPR Carbon bez kontroli 100 ozn.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958944
Basic UDI-DI: 59026439CRTL916RB
Reference: 1-916-1001
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958562

Crypto + Giardia kasetki 20 szt.

IVD Class BIVDR 2017/746On the market

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958562
Basic UDI-DI: 59026439BRT344JQ
Reference: 1-344-K020
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958449

Clostridium difficile GDH+A+B kas. 20szt

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958449
Basic UDI-DI: 59026439BRT327JQ
Reference: 1-327-K020
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958418

Giardia kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958418
Basic UDI-DI: 59026439BRT325JL
Reference: 1-325-K020
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958364

Clostridium difficile GDH kasetki 20 szt

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958364
Basic UDI-DI: 59026439BRT320JA
Reference: 1-320-K020
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958357

Campylobacter kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958357
Basic UDI-DI: 59026439BRT319JR
Reference: 1-319-K020
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958159

Syfilis kasetki 40 szt.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958159
Basic UDI-DI: 59026439CRT308JZ
Reference: 1-308-K040
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

05902643958111

H. pylori Ag w kale - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958111
Basic UDI-DI: 59026439BRT302J8
Reference: 1-302-K020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

05902643958104

H. pylori Ab - kasetki 20 szt.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958104
Basic UDI-DI: 59026439BRT301J6
Reference: 1-301-K020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

04049095140631

RIDA®Quick C. difficile GDH Toxin A/B Combi

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140631
Basic UDI-DI: 4049095N082300000XC
Reference: N0823
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

BIOSYNEX C. difficile GDH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678592862
Basic UDI-DI: 353267F00076P8N
Reference: 1030008
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

Crystal

Immunochromatographic One Step Rapid Visual Test for Vibrio cholerae – Dipstick

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ARKRAY Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000019015
UDI-DI: 08904226008289
Basic UDI-DI: 8904226016IC101TN
Reference: 16IC101-50
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Arazy Group GmbH
Last updated: 01.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

Crystal

Crystal® VC - O1

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: ARKRAY Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000019015
UDI-DI: 08904226000719
Basic UDI-DI: 8904226016IC211TW
Reference: 16IC211-10
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Arazy Group GmbH
Last updated: 01.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

AllCheck Syphilis Anti-TP

CHR20

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CALTH Inc.
Manufacturer SRN: KR-MF-000044697
UDI-DI: 08800061800296
Basic UDI-DI: 88000618W010509CHR20ZL
Reference: CHR20
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): CH-SSP-20 · Rev. 0
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:21

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

VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA

VRF002

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290777
Basic UDI-DI: 843661029VRF00201QW
Reference: VRF002
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:33

Manufacturer products View details

RPR-DAT

TREPONEMADAT

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323936
Basic UDI-DI: 803389132TREPONEMADAT0048
Reference: 26030
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

Chlamydia Trachomatis Rapid Test

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: 06977775222194
Basic UDI-DI: 693869768001RJ
Reference: 8001C01P25
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Belgium
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760032
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(2T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760025
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(1T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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