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109 device results listed.

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06955792743519

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743519
Basic UDI-DI: B-06955792743519
Reference: S3358E-50
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743502

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743502
Basic UDI-DI: B-06955792743502
Reference: S3358E-25
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743496

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743496
Basic UDI-DI: B-06955792743496
Reference: S3358E-5
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743489

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743489
Basic UDI-DI: B-06955792743489
Reference: S3358E-1
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743472

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743472
Basic UDI-DI: B-06955792743472
Reference: S3356E-50
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743458
Basic UDI-DI: B-06955792743458
Reference: S3356E-5
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743441

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743441
Basic UDI-DI: B-06955792743441
Reference: S3356E-1
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.CMV

CMV.400

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000407
Basic UDI-DI: B-05051716000407
Reference: CMV.400
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Wallac Oy
Last updated: 02.08.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.COVID

COV.435/300

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000193
Basic UDI-DI: B-05051716000193
Reference: COV.435/300
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Oxford Immunotec (Ireland) Ltd
Last updated: 02.08.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

EXTRACTION ENZYME

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013111
Basic UDI-DI: 5032384StrepGroupReagD7
Reference: DR0593G
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

PROSPECT WASH BUFFER

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519828
Basic UDI-DI: 5032384ProSpecTWashDM
Reference: R2450001
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia TB-Neo Extraction Buffer 20mL/Bottle

Capilia TB-Neo Extraction Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815008772
Basic UDI-DI: 4987815TB02A3
Reference: CATB0877
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Portugal
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fungifast

CGNFF001

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Credence Genomics Pvt. Ltd.
Manufacturer SRN: LK-MF-000045860
UDI-DI: 04793002939015
Basic UDI-DI: 4793002939FungifastXT
Reference: CGNFF001.100
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-697419997WR

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: JOYSBIO(Tianjin) Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003953
UDI-DI: D-697419997WR
Basic UDI-DI: B-697419997WR
Reference: joysbio 01
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

JDBIOTECH

JTBAG

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jei Daniel (JD) Biotech Corp.
Manufacturer SRN: CN-MF-000039637
UDI-DI: D-69301021JTBAGG3E5
Basic UDI-DI: B-69301021JTBAGG3E5
Reference: JTBAG
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

ViraChip Chromogen / Substrate Solution

Substrate

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRUVCUCS1
Basic UDI-DI: ++EVIRSubstrateKT
Reference: V-UVCUCS
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:24

Manufacturer products View details

ViraChip® AP-Anti-Human IgA Conjugate

Conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRUVCAKI1
Basic UDI-DI: ++EVIRConjugate5E
Reference: V-UVCAKI
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:24

Manufacturer products View details

ViraChip Wash Buffer Plus

Universal Reagent without Cells or Tissues

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: +EVIRUVCPWP1
Basic UDI-DI: ++EVIRReagentwithoutCoT8P
Reference: V-UVCPWP
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:21

Manufacturer products View details

ViraChip Sample Buffer Plus

Universal Reagent with Cells or Tissues or Derivatives thereof

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: +EVIRUVCPPP1
Basic UDI-DI: ++EVIRReagentwithCoTQB
Reference: V-UVCPPP
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:21

Manufacturer products View details

Verd.-/Waschpuffer Dilution-/Washbuffer LINE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIWE2000809
Basic UDI-DI: ++ENTIWE20008V037L
Reference: WE200.08
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details