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Alinity m

ALINITY M STI

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049277
Basic UDI-DI: 0884999AMN0039WP
Reference: 09N17-091
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

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Alinity m

ALINITY M STI

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999047938
Basic UDI-DI: 0884999AMN0917XS
Reference: 09N17-080
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

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Vaginal pH Rapid Test Cassette (Vaginal Secretions)

VPH-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-VPH-502aL8
Basic UDI-DI: B-VPH-502aL8
Reference: VPH-502a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Strip (Swab)

VPH-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-VPH-501aL5
Basic UDI-DI: B-VPH-501aL5
Reference: VPH-501a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNVC-CED-05XA

Neisseria Gonorrhoeae & Ureaplasma Urealyticum kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-05XA
Basic UDI-DI: B-TD-HNVC-CED-05XA
Reference: /
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:58

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D-TD-HNVC-CED-02X4

Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-02X4
Basic UDI-DI: B-TD-HNVC-CED-02X4
Reference: /
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

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Cwingene STI Multiplex Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST1702E3
Basic UDI-DI: B-ST1702E3
Reference: ST170(21V, 21Y, 21V-1, 21Y-1, 21V-2, 21Y-2, 21V-3, 21Y-3, 22U, 22X, 22U-1, 22X-1, 22U-2, 22X-2, 22U-3, 22X-3)
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene STI Multiplex Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST11MZ
Basic UDI-DI: B-ST11MZ
Reference: ST11021V, ST11022U, ST13021W, ST13022U, ST14021X, ST14022X, ST14023W, ST15023P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

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Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST01MW
Basic UDI-DI: B-ST01MW
Reference: ST01021V, ST01022U
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel 21 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP23021VA5
Basic UDI-DI: B-RP23021VA5
Reference: RP23021V
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

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Cowingene Respiratory Pathogen Panel Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP13MA
Basic UDI-DI: B-RP13MA
Reference: RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 2

RP2-P7-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP2-P7-10YM
Basic UDI-DI: B-RP2-P7-10YM
Reference: RP2-P7-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.0

RP1-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP1-P10-10NG
Basic UDI-DI: B-RP1-P10-10NG
Reference: RP1-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Influenza A/B and RSV Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP03M7
Basic UDI-DI: B-RP03M7
Reference: RP03021X, RP03022X, RP03023W
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.1

RP-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP-P10-10XX
Basic UDI-DI: B-RP-P10-10XX
Reference: RP-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Bacterial Vaginosis plus Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103203
Basic UDI-DI: 924010SD10159GU
Reference: SD10320Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Candidiasis Assay

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101780
Basic UDI-DI: 924010SD98030LF
Reference: SD10178Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101575
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103210
Basic UDI-DI: 924010SD97500LQ
Reference: SD10321Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Strip (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGVPH-501aLF
Basic UDI-DI: B-OGVPH-501aLF
Reference: VPH-501a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details