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15 device results listed.

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Microsporidia IFAT

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158218105
Basic UDI-DI: 7640158218100ZS
Reference: 8100
EMDN: W0104050299
EMDN description: DETECTION AND IDENTIFICATION (PARASITOLOGY) - OTHER
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 01.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

TRICHOMONAS SELECTIVE MEDIUM

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384027521
Basic UDI-DI: 5032384TrichomonasAgar26U
Reference: EB0861C
EMDN: W0104050299
EMDN description: DETECTION AND IDENTIFICATION (PARASITOLOGY) - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

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TRICHOMONAS MEDIUM NO. 2

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384028689
Basic UDI-DI: 5032384TrichomonasAgarN7
Reference: LR0027A
EMDN: W0104050299
EMDN description: DETECTION AND IDENTIFICATION (PARASITOLOGY) - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

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PROSPECT CRYPTOSPORIDIUM MICROPLATE ASSAY

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384503940
Basic UDI-DI: 5032384PSCrypto43
Reference: R2454096
EMDN: W0104050203
EMDN description: CRYPTOSPORIDIUM
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

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Pneumo CEL Indirect IFA

Pneumo CEL Indirect IFA (50T)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KP2D7
Basic UDI-DI: B-KP2D7
Reference: KP2
EMDN: W0104050201
EMDN description: PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)
First on market country: Portugal
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

Crypto+Giardia Antigen Rapid Test

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: D-CryptoGiardiaFB
Basic UDI-DI: B-CryptoGiardiaFB
Reference: Cassette
EMDN: W0104050203
EMDN description: CRYPTOSPORIDIUM
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 14:14

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08885019710674

300208

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710674
Basic UDI-DI: B-08885019710674
Reference: 300208
EMDN: W0104050201
EMDN description: PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

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08885019710667

300207

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710667
Basic UDI-DI: B-08885019710667
Reference: 300207
EMDN: W0104050201
EMDN description: PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

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PneumoGenius® Multiplex real-time PCR kit

PN-600

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750941
Basic UDI-DI: B-08719326750941
Reference: PN-600
EMDN: W0104050201
EMDN description: PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:05

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LyoSens Plasmodium falciparum Detection qPCR Kit

LYO70

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259882
Basic UDI-DI: B-08683548259882
Reference: LYO70
EMDN: W0104050202
EMDN description: PLASMODIUM FALCIPARUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

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ChainFor Plasmodium falciparum Detection qPCR Kit

CFP99

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257956
Basic UDI-DI: B-08683548257956
Reference: CFP99
EMDN: W0104050202
EMDN description: PLASMODIUM FALCIPARUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

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06974323010982

Real-time PCR Detection Kit for Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010982
Basic UDI-DI: B-06974323010982
Reference: ID045
EMDN: W0104050202
EMDN description: PLASMODIUM FALCIPARUM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

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06974323010975

Real-time PCR Detection Kit for Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010975
Basic UDI-DI: B-06974323010975
Reference: ID045
EMDN: W0104050202
EMDN description: PLASMODIUM FALCIPARUM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

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Cryptosporidium Parvum Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910216
Basic UDI-DI: B-06974238910216
Reference: HCRY031G
EMDN: W0104050203
EMDN description: CRYPTOSPORIDIUM
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658552306
Basic UDI-DI: B-04260658552306
Reference: 8.16.01.0.0020
EMDN: W0104050203
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:34

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