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246 device results listed.

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Malaria Pf (HRP2) Ag Rapid Test Kit

SC20102W-25T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20102W-25TVS
Basic UDI-DI: B-SC20102W-25TVS
Reference: SC20102W-25T
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf (HRP2) Ag Rapid Test Kit

SC20102W-20T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20102W-20TVB
Basic UDI-DI: B-SC20102W-20TVB
Reference: SC20102W-20T
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf (HRP2) Ag Rapid Test Kit

SC20102W-1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC20102W-1TZC
Basic UDI-DI: B-SC20102W-1TZC
Reference: SC20102W-1T
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022036EK
Basic UDI-DI: B-SAC2022036EK
Reference: SAC2022036
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022035EH
Basic UDI-DI: B-SAC2022035EH
Reference: SAC2022035
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022034EF
Basic UDI-DI: B-SAC2022034EF
Reference: SAC2022034
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022012E5
Basic UDI-DI: B-SAC2022012E5
Reference: SAC2022012
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022011E3
Basic UDI-DI: B-SAC2022011E3
Reference: SAC2022011
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022010DZ
Basic UDI-DI: B-SAC2022010DZ
Reference: SAC2022010
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022009EG
Basic UDI-DI: B-SAC2022009EG
Reference: SAC2022009
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022001DY
Basic UDI-DI: B-SAC2022001DY
Reference: SAC2022001
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

Malaria P.f./P.v. Rapid Test

Malaria P.f./P.v. Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAL-D22bBY
Basic UDI-DI: B-MAL-D22bBY
Reference: MAL-D22b
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.an. Rapid Test

Malaria P.f./P.an. Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAL-D22aBW
Basic UDI-DI: B-MAL-D22aBW
Reference: MAL-D22a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Rapid Test

Malaria P.f./P.v. Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: D-MALAC1-023G
Basic UDI-DI: B-MALAC1-023G
Reference: MALAC1-02
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Antigen Rapid Test

Malaria P.f. Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAL-D02aBL
Basic UDI-DI: B-MAL-D02aBL
Reference: MAL-D02a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Antibody Rapid Test

Leishmania IgG/IgM Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-L-D22a43
Basic UDI-DI: B-L-D22a43
Reference: L-D22a
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Crypto/Giardia CEL IFA

Crypto/Giardia CEL IFA (50T)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KR2DD
Basic UDI-DI: B-KR2DD
Reference: KR2
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Italy
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. /P.v. Rapid Test Cassette

Malaria P.f. /P.v. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPV-R402K9
Basic UDI-DI: B-IMPV-R402K9
Reference: IMPV-R402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-401M8
Basic UDI-DI: B-IMPN-401M8
Reference: IMPN-401
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Rapid Test Cassette

Malaria P.f./Pan Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-R402FZ
Basic UDI-DI: B-IMPN-R402FZ
Reference: IMPN-R402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details