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19.09.2026 23:43

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98 device results listed.

Page 5 / 5

HOKAPI™ NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404595
Basic UDI-DI: 69713904301127E
Reference: 010112001
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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

Neuronen-Spezifische Enolase (eCLIA)

-

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062570
Basic UDI-DI: 69703416803205025JB
Reference: 0320501603
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236095
Basic UDI-DI: 697846523enzymeC01U4
Reference: 2×100 test
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236088
Basic UDI-DI: 697846523enzymeC01U4
Reference: 100 tests
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236071
Basic UDI-DI: 697846523enzymeC01U4
Reference: 2×50 test
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236064
Basic UDI-DI: 697846523enzymeC01U4
Reference: 50 tests
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236057
Basic UDI-DI: 697846523enzymeC01U4
Reference: 25 tests
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439685
Basic UDI-DI: 69713904301127E
Reference: 010112101
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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

Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522642689
Basic UDI-DI: B-06970522642689
Reference: DD0801
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

NSE CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908379
Basic UDI-DI: 697015090000013GR
Reference: CMB1102
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

NSE CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150905514
Basic UDI-DI: 697015090000013GR
Reference: CMB1101
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL NSE (CLIA)

MAGICL NSE (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798302
Basic UDI-DI: B-06954414798302
Reference: /
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron Specific Enolase CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590827
Basic UDI-DI: 697518250F12212ZV
Reference: F12212
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

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: 06941967231127
Basic UDI-DI: B-06941967231127
Reference: 0602001
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404601
Basic UDI-DI: 69713904301127E
Reference: 010112601
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300612
Basic UDI-DI: B-06937287300612
Reference: 100 tests/kit
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-Specific Enolase Kit (CLIA)

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IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751352
Basic UDI-DI: B-06936595751352
Reference: FG1213Y
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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

NSE Rapid Quantitative Test

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207923
Basic UDI-DI: B-06933260207923
Reference: BT0200401
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details