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823 device results listed.

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CerTest C. difficile GDH+Toxin A+B

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200376
Basic UDI-DI: 84354402IDXGASTROB_GX7Q
Reference: GX872001V
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

CerTest Clostridium difficile Toxin A+B

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200369
Basic UDI-DI: 84354402IDXGASTROB_CD64
Reference: CD882001V
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

CerTest Clostridium difficile antigen GDH

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200345
Basic UDI-DI: 84354402IDXGASTROB_GD6G
Reference: GD820001V
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

CerTest H. pylori

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200314
Basic UDI-DI: 84354402IDXGASTROB_P4P
Reference: P820001V
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

SCREEN® Strep A Test

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983117289
Basic UDI-DI: 6970277510014PYS
Reference: 987814454
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Czechia
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 10:56

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

NADAL® Gonorrhea Test

Gonorrhea Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-611905N-102D
Basic UDI-DI: B-nvm-611905N-102D
Reference: 611905N-10
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® H.pylori Ag Test

H.pylori Ag Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-262002S6
Basic UDI-DI: B-nvm-262002S6
Reference: 262002
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

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NADAL® H.pylori Ab Test

H.pylori Ab Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-262001S4
Basic UDI-DI: B-nvm-262001S4
Reference: 262001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® Strep B

Strep B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-232001R3
Basic UDI-DI: B-nvm-232001R3
Reference: 232001
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Strep A Plus Test

Strep A Plus Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-222907N-20YR
Basic UDI-DI: B-nvm-222907N-20YR
Reference: 222907N-20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-222901N-20WP
Basic UDI-DI: B-nvm-222901N-20WP
Reference: 222901N-20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

dedicio® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-222901D-20UH
Basic UDI-DI: B-nvm-222901D-20UH
Reference: 222901D-20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-222001AV9
Basic UDI-DI: B-nvm-222001AV9
Reference: 222001A
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-221901N-40WA
Basic UDI-DI: B-nvm-221901N-40WA
Reference: 221901N-40
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

dedicio® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-221901D-20TW
Basic UDI-DI: B-nvm-221901D-20TW
Reference: 221901D-20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Strep A Test

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-221001AUW
Basic UDI-DI: B-nvm-221001AUW
Reference: 221001A
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Chlamydia Test (CE0197)

Chlamydia Test (CE0197)

IVD Annex II List BIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-212007QR
Basic UDI-DI: B-nvm-212007QR
Reference: 212007
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

Bio·Firm

WI-GON-C71-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-GON-C71-25FZ
Basic UDI-DI: B-WI-GON-C71-25FZ
Reference: WI-GON-C71-25
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: OSEN GmbH
Last updated: 15.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-W39-SH9D

One Step Strep A Swab Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W39-SH9D
Basic UDI-DI: B-W39-SH9D
Reference: W39-SH
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W39-CH7V

One Step Strep A Swab Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W39-CH7V
Basic UDI-DI: B-W39-CH7V
Reference: W39-CH
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details