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313 device results listed.

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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

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)

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

Lysergic acid diethylamide(LSD) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LSD001LN2H
Basic UDI-DI: B-697424646LSD001LN2H
Reference: LSD-1011/LSD-1012/LSD-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

Luteinizing Hormone(LH) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LH001FEGA
Basic UDI-DI: B-697424646LH001FEGA
Reference: LH-1011/LH-1012/LH-1013
EMDN: W0102160304
EMDN description: LH - 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

Luteinizing Hormone(LH) Rapid Test Kit (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LH000FCFZ
Basic UDI-DI: B-697424646LH000FCFZ
Reference: LH-1011/LH-1012/LH-1013
EMDN: W0102160304
EMDN description: LH - RT & POC
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

Lysergic acid diethylamide(LSD) Rapid Test Kit(Urine)

LSD-1011/LSD-1012/LSD-1014

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LSD000LL28
Basic UDI-DI: B-697424646LSD000LL28
Reference: LSD-1011/LSD-1012/LSD-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

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)

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)

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

Kratom(KRA) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646KRA001K9WQ
Basic UDI-DI: B-697424646KRA001K9WQ
Reference: KRA-1011/KRA-1012/KRA-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

Kratom Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646KRA000K7WF
Basic UDI-DI: B-697424646KRA000K7WF
Reference: KRA-1011/KRA-1012/KRA-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

Ketamine(KET) Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646KET001JXZB
Basic UDI-DI: B-697424646KET001JXZB
Reference: KET-1011/KET-1012/KET-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

Ketamine(KET) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646KET000JVZ2
Basic UDI-DI: B-697424646KET000JVZ2
Reference: KET-1011/KET-1012/KET-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY 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

Synthetic Cannabis(K2) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646K2U001CYPK
Basic UDI-DI: B-697424646K2U001CYPK
Reference: K2-1011/K2-1012/K2-1014
EMDN: W0102160505
EMDN description: CANNABINOIDS - 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

Synthetic Cannabis Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646K2S001CJMT
Basic UDI-DI: B-697424646K2S001CJMT
Reference: K2-7011/K2-7012/K2-7014
EMDN: W0102160505
EMDN description: CANNABINOIDS - 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

Synthetic Cannabis(K2) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646K2000AE6L
Basic UDI-DI: B-697424646K2000AE6L
Reference: K2-1011/K2-1012/K2-1014
EMDN: W0102160505
EMDN description: CANNABINOIDS - RT & POC
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

Synthetic Cannabis(K2) Rapid Test (Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646K2(S)000AFZ
Basic UDI-DI: B-697424646K2(S)000AFZ
Reference: K2-7012/K2-7014/K2-7015
EMDN: W0102160505
EMDN description: CANNABINOIDS - RT & POC
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

Hantavirus 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-697424646HV001H4K2
Basic UDI-DI: B-697424646HV001H4K2
Reference: HV-4012
EMDN: W0105099099
EMDN description: VIROLOGY - 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