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Syphilis Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCSYP-D-LWR
Basic UDI-DI: B-SCSYP-D-LWR
Reference: Syphilis Control
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490503
Basic UDI-DI: B-06975679490503
Reference: HU-RE-F07F032002
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ORF-R302L6
Basic UDI-DI: B-ORF-R302L6
Reference: ORF-R302
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OSA-R402JT
Basic UDI-DI: B-OSA-R402JT
Reference: OSA-R402
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

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SP-10 Male Fertility Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OSP-R902RP
Basic UDI-DI: B-OSP-R902RP
Reference: OSP-R902
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

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CA125 Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-T125-R402EM
Basic UDI-DI: B-T125-R402EM
Reference: T125-R402
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

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CA15-3 Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-T153-R402FE
Basic UDI-DI: B-T153-R402FE
Reference: T153-R402
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490510
Basic UDI-DI: B-06975679490510
Reference: HU-RE-F07F034002
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

möLab® Drogen Multi-Line Test 10-fach (AMP,BAR,BZD,COC,THC,MET,MTD,MOR,TCA,MDMA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: möLab GmbH
Manufacturer SRN: DE-MF-000022941
UDI-DI: D-0271099WF
Basic UDI-DI: B-0271099WF
Reference: 0271099
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 22:49

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LyoSens™

Ureaplasma parvum qPCR Kit

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259028
Basic UDI-DI: B-08683548259028
Reference: PCR60
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 12.08.2026 22:49

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PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490466
Basic UDI-DI: B-06975679490466
Reference: HU-RE-F07F046002
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

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LyoSens™

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275798
Basic UDI-DI: B-08684998275798
Reference: PCR60
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

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IL-6 Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490459
Basic UDI-DI: B-06975679490459
Reference: HU-RE-F07F047002
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275828
Basic UDI-DI: B-08684998275828
Reference: PCR60
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

ChainFor™

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031988
Basic UDI-DI: B-08684595031988
Reference: PCR60
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

D-Dimer Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490435
Basic UDI-DI: B-06975679490435
Reference: HU-RE-F07F045002
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032480
Basic UDI-DI: B-08684595032480
Reference: PCR60
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

ChainFor™

CFP88

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257857
Basic UDI-DI: B-08683548257857
Reference: PCR60
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

NT-proBNP Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490411
Basic UDI-DI: B-06975679490411
Reference: HU-RE-F07F061002
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490404
Basic UDI-DI: B-06975679490404
Reference: HU-RE-F08F027002
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details