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197 device results listed.

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06941571810008

R10-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571810008
Basic UDI-DI: B-06941571810008
Reference: R10-110
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100939
Basic UDI-DI: B-06936983100939
Reference: IMPVF-402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020092

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020092
Basic UDI-DI: B-06936791020092
Reference: EX0402-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020085

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020085
Basic UDI-DI: B-06936791020085
Reference: EX0401-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020078

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020078
Basic UDI-DI: B-06936791020078
Reference: EX0301-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Malaria pf/pan Antigen Test Card

1Q10C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711083
Basic UDI-DI: B-06921963711083
Reference: 1Q10C2
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Malaria pf/pv Antigen Test Card

1Q07C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711076
Basic UDI-DI: B-06921963711076
Reference: 1Q07C2
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Malaria pf Antigen Test Card

1Q06C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711069
Basic UDI-DI: B-06921963711069
Reference: 1Q06C2
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Malaria pan Antigen Test Card

1Q05C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711052
Basic UDI-DI: B-06921963711052
Reference: 1Q05C2
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104715
Basic UDI-DI: 6970277510000HXR
Reference: IMPV-N402-20
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. /Pan Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104685
Basic UDI-DI: 6970277510000GXP
Reference: IMPN-N402-20
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf/pan One Step Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304558
Basic UDI-DI: B-69743840304558
Reference: 3020603
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf/pv One Step Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304480
Basic UDI-DI: B-69743840304480
Reference: 3020602
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.v./Pan Rapid Test (Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL005GVVC
Basic UDI-DI: B-697424646MAL005GVVC
Reference: MAL-4022c
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Rapid Test (Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL004GTV3
Basic UDI-DI: B-697424646MAL004GTV3
Reference: MAL-4022b
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Rapid Test (Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL003GRUS
Basic UDI-DI: B-697424646MAL003GRUS
Reference: MAL-4022a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Rapid Test Kit(Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL003GKUC
Basic UDI-DI: B-697424646MAL003GKUC
Reference: MAL-4022b
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Rapid Test (Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL002GPUH
Basic UDI-DI: B-697424646MAL002GPUH
Reference: MAL-4011c/MAL-4012c
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Rapid Test Kit(Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL002GKU7
Basic UDI-DI: B-697424646MAL002GKU7
Reference: MAL-4022a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.v. Rapid Test (Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MAL001GMU6
Basic UDI-DI: B-697424646MAL001GMU6
Reference: MAL-4011b/MAL-4012b
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details