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TREN

Last updated

22.09.2026 16:13

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3537230

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Active filter:EMDN:W0105090401

197 device results listed.

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Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit

SC20202W-20T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent
Manufacturer
Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000014691
UDI-DI
D-SC20202W-20TVW
Basic UDI-DI
B-SC20202W-20TVW
Reference
SC20202W-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 productsAuthorised representative productsAuthorised representative actorsView details
Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit

SC20202W-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-SC20202W-1TZV
Basic UDI-DI
B-SC20202W-1TZV
Reference
SC20202W-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 productsAuthorised representative productsAuthorised representative actorsView details
Malaria Pf (HRP2) Ag Rapid Test Kit

SC20102W-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent
Manufacturer
Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000014691
UDI-DI
D-SC20102W-50TVS
Basic UDI-DI
B-SC20102W-50TVS
Reference
SC20102W-50T
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 productsAuthorised representative productsAuthorised representative actorsView details
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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView details
BGI

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 productsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
D-IMPN-401M8

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 productsAuthorised representative productsAuthorised representative actorsView details