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61 device results listed.

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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: 06972719604425
Basic UDI-DI: B-06972719604425
Reference: 50tests/kit
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:46

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972719602919
Basic UDI-DI: B-06972719602919
Reference: 50tests/kit
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972719602902
Basic UDI-DI: B-06972719602902
Reference: 50tests/kit
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972719602896
Basic UDI-DI: B-06972719602896
Reference: 100tests/kit
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972719600755
Basic UDI-DI: B-06972719600755
Reference: 215760006
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:33

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA 21-1 Assay Reagent Kit (CMIA)

C2KA007

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053335
Basic UDI-DI: B-06971792053335
Reference: C2KA007
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

ELSA-CYFRA-

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321159
Basic UDI-DI: B-03770024321159
Reference: ELSA-CYFRA-
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ichroma™ Cyfra21-1

ichroma™ Cyfra21-1

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043929
Basic UDI-DI: 880613300131BK
Reference: CFPC-140
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CYFRA 21-1

HOKAPI™ CYFRA 21-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404557
Basic UDI-DI: 69713904301107A
Reference: 010110001
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CYFRA 21-1

HOKAPI™ CYFRA 21-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439661
Basic UDI-DI: 69713904301107A
Reference: 010110101
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:01

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment (CYFRA21-1) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×6

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522641941
Basic UDI-DI: B-06970522641941
Reference: DD1603
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA 21-1 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359508940
Basic UDI-DI: 697015090000226HC
Reference: CMB1210
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment 21-1 Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581016
Basic UDI-DI: 697518250P122086B
Reference: P12208
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231509
Basic UDI-DI: B-06941967231509
Reference: 0603901
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CYFRA 21-1

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404564
Basic UDI-DI: 69713904301107A
Reference: 010110601
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fragments of Cytokeratin 19 Kit(CLIA)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751321
Basic UDI-DI: B-06936595751321
Reference: FG1210Y
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207619
Basic UDI-DI: B-06933260207619
Reference: BT0506305
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207602
Basic UDI-DI: B-06933260207602
Reference: BT0506304
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207596
Basic UDI-DI: B-06933260207596
Reference: BT0506303
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207589
Basic UDI-DI: B-06933260207589
Reference: BT0506302
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details