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246 device results listed.

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

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)

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)

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)

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

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

Malaria P.f. 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-697424646MAL001GKU2
Basic UDI-DI: B-697424646MAL001GKU2
Reference: MAL-4011/MAL-4012a
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.f. Rapid Test (Whole Blood)

Malaria P.f. 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-697424646MAL000GKTV
Basic UDI-DI: B-697424646MAL000GKTV
Reference: MAL-4011a/MAL-4012a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)

Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LEI002GZVF
Basic UDI-DI: B-697424646LEI002GZVF
Reference: LEI-3021/LEI-3022
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LEI001GXV6
Basic UDI-DI: B-697424646LEI001GXV6
Reference: LEI-4021/LEI-4022
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmaniasis Rapid Test (Whole Blood/serum/plasma)

Leishmaniasis Rapid Test (Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LEI000GVUV
Basic UDI-DI: B-697424646LEI000GVUV
Reference: LEI-4011/LEI-4012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Rapid Test (Serum/Plasma)

Chagas Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHA002CMM9
Basic UDI-DI: B-697424646CHA002CMM9
Reference: CHA-3011/CHA-3012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Rapid Test (WB/S/P)

Chagas Rapid Test (WB/S/P)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHA001CKLY
Basic UDI-DI: B-697424646CHA001CKLY
Reference: CHA-4011/CHA-4012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Rapid Test (Whole Blood/Serum/Plasma)

Chagas Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHA000CHLM
Basic UDI-DI: B-697424646CHA000CHLM
Reference: CHA-4011/CHA-4012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

MAL-W21- FV（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712009038Z
Basic UDI-DI: B-69717712009038Z
Reference: MAL-W21- FV（25PCS）
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

6970277510023AXW

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 6970277510023AXW
Basic UDI-DI: B-6970277510023AXW
Reference: IMPV-401
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)

MA-Pan/Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991703QP
Basic UDI-DI: B-693757991703QP
Reference: MA-Pan/Pf 50170301 MA-Pan/Pf 25170302
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)

MA-Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991702QM
Basic UDI-DI: B-693757991702QM
Reference: MA-Pf 50170101 MA-Pf 25170102
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)

MA-Pf/Pv strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991701QK
Basic UDI-DI: B-693757991701QK
Reference: MA-Pf/Pv 50170201 MA-Pf/Pv 25170202
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax

Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723590
Basic UDI-DI: B-62230182723590
Reference: D-796 001
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Crypto+Giardia+Entamoeba

CerTest Crypto+Giardia+Entamoeba

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440212584
Basic UDI-DI: 84354402IDXGASTROB_NE77
Reference: NE872001V
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

CerTest Crypto+Giardia

CerTest Crypto+Giardia

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440211914
Basic UDI-DI: 84354402IDXGASTROB_NW8B
Reference: NW882001V
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details