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Cardiac Markers Combo Rapid Test (Serum/Plasma) （CTNI/CKMB/MYO）

Cardiac Markers Combo Rapid Test (Serum/Plasma) （CTNI/CKMB/MYO）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CMC002ESRA
Basic UDI-DI: B-697424646CMC002ESRA
Reference: CMC-3032a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
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

Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) （CTNI/CKMB/MYO）

Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) （CTNI/CKMB/MYO）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CMC001EQQZ
Basic UDI-DI: B-697424646CMC001EQQZ
Reference: CMC-4032a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
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

Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) （CTNI/CKMB/MYB）

Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) （CTNI/CKMB/MYB）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CMC000ENQN
Basic UDI-DI: B-697424646CMC000ENQN
Reference: CMC-4032a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
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

Creatine Kinase-MB(CKMB) Rapid Test (Serum/Plasma)

Creatine Kinase-MB(CKMB) 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-697424646CKMB002NTBF
Basic UDI-DI: B-697424646CKMB002NTBF
Reference: CKMB-3012
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
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

Creatine Kinase-MB(CKMB) Rapid Test (Whole Blood/Serum/Plasma)

Creatine Kinase-MB(CKMB) 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-697424646CKMB001NRB6
Basic UDI-DI: B-697424646CKMB001NRB6
Reference: CKMB-4012
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
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

MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma)

MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CKMB001FX8RT
Basic UDI-DI: B-697424646CKMB001FX8RT
Reference: CKMB-3012F
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
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

Creatine Kinase-MB Rapid Test (Whole Blood/Serum/Plasma)

Creatine Kinase-MB 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-697424646CKMB000NPAV
Basic UDI-DI: B-697424646CKMB000NPAV
Reference: CKMB-4012
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
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

MB Isoenzyme of Creatine Kinase FIA Test (Whole blood/Serum/Plasma)

MB Isoenzyme of Creatine Kinase FIA 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-697424646CKMB000FX5RE
Basic UDI-DI: B-697424646CKMB000FX5RE
Reference: CKMB-4012F
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
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

Cannabidiol(CBD) Rapid Test(Saliva)

Cannabidiol(CBD) Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CBD002B8HX
Basic UDI-DI: B-697424646CBD002B8HX
Reference: CBD-7014
EMDN: W0102160506
EMDN description: COCAINE + COCAINE METABOLITES - RT & POC
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

Cannabidiol Rapid Test(Urine)

Cannabidiol Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CBD001B6HN
Basic UDI-DI: B-697424646CBD001B6HN
Reference: CBD-1011/CBD-1012/CBD-1014
EMDN: W0102160505
EMDN description: CANNABINOIDS - RT & POC
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

GHB Rapid Test(Urine)

GHB Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CBD000B4HD
Basic UDI-DI: B-697424646CBD000B4HD
Reference: GHB-1011/GHB-1012/GHB-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Antigen Rapid Test (Feces)

Calprotectin Antigen Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CAL001CKMQ
Basic UDI-DI: B-697424646CAL001CKMQ
Reference: CAL-5012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS 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

Calprotein Rapid Test (Feces)

Calprotein Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CAL000CHMD
Basic UDI-DI: B-697424646CAL000CHMD
Reference: CAL-5012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS 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

Benzodiazepine(BZO) Rapid Test (Urine)

Benzodiazepine(BZO) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BZO001ME4A
Basic UDI-DI: B-697424646BZO001ME4A
Reference: BZO-1011/BZO-1012/BZO-1014
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
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

Benzodiazepine(BZO) Rapid Test Kit(Urine)

Benzodiazepine(BZO) 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-697424646BZO000MC3Z
Basic UDI-DI: B-697424646BZO000MC3Z
Reference: BZO-1011/BZO-1012/BZO-1014
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
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

Buprenorphine(BUP) Rapid Test (Urine)

Buprenorphine(BUP) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BUP001KW2Y
Basic UDI-DI: B-697424646BUP001KW2Y
Reference: BUP-1011/BUP-1012/BUP-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 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine(BUP) Rapid Test Kit(Urine)

Buprenorphine(BUP) 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-697424646BUP000KU2P
Basic UDI-DI: B-697424646BUP000KU2P
Reference: BUP-1011/BUP-1012/BUP-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 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-Brain Natriuretic Peptide FIA Test (Serum/Plasma)

N-terminal pro-Brain Natriuretic Peptide FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BNP001FN48F
Basic UDI-DI: B-697424646BNP001FN48F
Reference: BNP-3012F
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-Brain Natriuretic Peptide FIA Test (Whole blood/Serum/Plasma)

N-terminal pro-Brain Natriuretic Peptide FIA 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-697424646BNP000FMZAF
Basic UDI-DI: B-697424646BNP000FMZAF
Reference: BNP-4012F
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Barbiturates(BAR) Rapid Test (Urine)

Barbiturates(BAR) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BAR001DGPE
Basic UDI-DI: B-697424646BAR001DGPE
Reference: BAR-1011/BAR-1012/BAR-1014
EMDN: W0102160503
EMDN description: BARBITURATES - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details