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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

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: 06976202760018
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(5T/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: 06976202760001
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(25T/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

LYHER

ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-40