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87 device results listed.

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CONE CAP MIDI SYSTEM

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: DURVIZ, S.L.
Manufacturer SRN: ES-MF-000004181
UDI-DI: 08437013961950
Basic UDI-DI: 8437013961MIDI5Z
Reference: RPP05A
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:55

Manufacturer products View details

REAL UNIVERSAL SYSTEM SAF

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: DURVIZ, S.L.
Manufacturer SRN: ES-MF-000004181
UDI-DI: 08437013961882
Basic UDI-DI: 8437013961UNIV9T
Reference: RPP1719
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:54

Manufacturer products View details

Non-Nutrient Agar (Page Amoeba Saline) (NN Agar)

Non-Nutrient Agar (Page Amoeba Saline) (NN Agar) 010392

IVD Class AIVDR 2017/746On the marketNo EU repProfessional testingReagentSingle useSterile

Manufacturer: G. PAPANIKOLAOU & CO. LP - Bioprepare
Manufacturer SRN: EL-MF-000055282
UDI-DI: 05212037700548
Basic UDI-DI: 52120377010392CR
Reference: 010392
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 23:46

Manufacturer products View details

Para-Pak® CON-Trate® Concentration System - 200

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733102721
Basic UDI-DI: 008407331PARAPAKCLA013ZA
Reference: 960200
EMDN: W0104050101
EMDN description: PARASITOLOGY EXTRACTION REAGENTS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Para-Pak® SVT

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733102073
Basic UDI-DI: 008407331PARAPAKCLA010Z4
Reference: 901612
EMDN: W0104050101
EMDN description: PARASITOLOGY EXTRACTION REAGENTS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Para-Pak® Ethyl Acetate

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733102059
Basic UDI-DI: 008407331PARAPAKCLA016ZG
Reference: FK4318
EMDN: W0104050101
EMDN description: PARASITOLOGY EXTRACTION REAGENTS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

FECONOMICS

FECAL HOMOGENIZATION AND CONCENTRATION KIT FOR MICROSCOPIC DETECTION OF PARASITES IN FECAL SAMPLES

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Innovative Biotechnology Organization Trade Limited Company
Manufacturer SRN: TR-MF-000037634
UDI-DI: 08681677201444
Basic UDI-DI: 86816772FCN6H
Reference: FCN010
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:33

Manufacturer products View details

NNN medium

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Oslo universitetssykehus HF
Manufacturer SRN: NO-MF-000028214
UDI-DI: 07073097800801
Basic UDI-DI: 7073097KOPPARROR029T
Reference: Not applicable
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:13

Manufacturer products View details

Amøbe saltvann

Amøbe dyrkningsmedium

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Oslo universitetssykehus HF
Manufacturer SRN: NO-MF-000028214
UDI-DI: 07073097800795
Basic UDI-DI: 7073097KOPPARROR01SKL0167
Reference: Not applicable
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:13

Manufacturer products View details

Formalin 10 % in sample container with spoon (94 x 8 ml), phosphate buffered pH 7.2 incl. 4 % formaldehyde

102256SCWS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: 06430074452773
Basic UDI-DI: 643007445102256SCWSJJ
Reference: 1S2256L
EMDN: W0104050199
EMDN description: PARASITOLOGY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:59

Manufacturer products View details