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64 device results listed.

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Vitamin B12 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406665
Basic UDI-DI: 697029753300KZ
Reference: HGCL66
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406658
Basic UDI-DI: 697029753291LR
Reference: HGCL67
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

α-fetoprotein test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700405644
Basic UDI-DI: 697029753439LZ
Reference: HGUPT17
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404876
Basic UDI-DI: 697029753068LL
Reference: HGCL24
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404852
Basic UDI-DI: 697029753279M3
Reference: HGCL32
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen test (Chemiluminescence Immunoassay)

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404845
Basic UDI-DI: 697029753066LG
Reference: HGCL23
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404814
Basic UDI-DI: 697029753296M3
Reference: HGCL19
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 125 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404791
Basic UDI-DI: 697029753280LL
Reference: HGCL26
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404784
Basic UDI-DI: 697029753278LZ
Reference: HGCL28
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404777
Basic UDI-DI: 697029753464LY
Reference: HGCL25
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404753
Basic UDI-DI: 697029753283LS
Reference: HGCL27
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404715
Basic UDI-DI: 697029753297M5
Reference: HGCL20
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404708
Basic UDI-DI: 697029753295LZ
Reference: HGCL18
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

MQ60 proB

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403503
Basic UDI-DI: 697029753MRBU3
Reference: HGMQ60 proB
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Total Thyroxine test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403497
Basic UDI-DI: 697029753294LX
Reference: HGCL40
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

α-fetoprotein test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404661
Basic UDI-DI: 697029753059LK
Reference: HGCL22
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin test(Chemiluminescence Immunoassay)

Please see the IFU

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

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404654
Basic UDI-DI: 697029753341LF
Reference: HGCL31
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

Please see IFU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403466
Basic UDI-DI: 697029753HG2J
Reference: HGMQ60
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibody rapid test (Colloidal Gold)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403442
Basic UDI-DI: 697029753312L8
Reference: HGCG02
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403435
Basic UDI-DI: 697029753311L6
Reference: HGCG01
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details