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45 device results listed.

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Pregnancy-associated Plasma Protein A (CLIA)

50T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081344
Basic UDI-DI: B-06978945081344
Reference: CA1373A
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA)

C2KJ004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753471296
Basic UDI-DI: B-06976753471296
Reference: C2KJ004
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay PAPP-A (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762971
Basic UDI-DI: B-06975070762971
Reference: 18716001
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982643
Basic UDI-DI: B-06974969982643
Reference: 200 Tests/kit（DR1124-3）
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982070
Basic UDI-DI: B-06974969982070
Reference: 100 Tests/kit（DR1124-2）
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969981509
Basic UDI-DI: B-06974969981509
Reference: 50 Tests/kit（DR1124-1）
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:11

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101578

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101578
Basic UDI-DI: B-06974671101578
Reference: DR-CLIA-CK-A026
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101479

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101479
Basic UDI-DI: B-06974671101479
Reference: DR-HO-A011
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607228

Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607228
Basic UDI-DI: B-06972719607228
Reference: 50tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607211

Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607211
Basic UDI-DI: B-06972719607211
Reference: 50tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607204

Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607204
Basic UDI-DI: B-06972719607204
Reference: 50tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607198

Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607198
Basic UDI-DI: B-06972719607198
Reference: 100tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607181

Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607181
Basic UDI-DI: B-06972719607181
Reference: 100tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

06972719607174

Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607174
Basic UDI-DI: B-06972719607174
Reference: 100tests/kit
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA)

C2KC011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051737
Basic UDI-DI: B-06971792051737
Reference: C2KC011
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

PAPP-A (eCLIA)

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515304W3
Basic UDI-DI: B-0320515304W3
Reference: 0320515304
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAPP-A (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515303VZ
Basic UDI-DI: B-0320515303VZ
Reference: 0320515303
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAPP-A (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515302VX
Basic UDI-DI: B-0320515302VX
Reference: 0320515302
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAPP-A (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515301VV
Basic UDI-DI: B-0320515301VV
Reference: 0320515301
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-associated plasma protein-A Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701366
Basic UDI-DI: B-06955792701366
Reference: S2093E-24
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details