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84 device results listed.

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Homocysteine (HCY) Test Kit (Enzymatic)

R1:48mL×1 R2:13mL×1（700081）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300427
Basic UDI-DI: B-06936895300427
Reference: R1:48mL×1 R2:13mL×1（700081）
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Homocysteine Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009381
Basic UDI-DI: B-06934175009381
Reference: 12600545
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HCY Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214327
Basic UDI-DI: B-06933260214327
Reference: BT2221-HCY
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Homocysteine Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_HCYS

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006128
Basic UDI-DI: 0405686900914VT
Reference: 10445897
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

N Latex HCY

IVDR_27_MAR EB_B_KIT _N_La_HCY

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006715
Basic UDI-DI: 0405686900882W7
Reference: 10445973
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 03:19

Manufacturer products View details

D-R073162N

R1: 48mL×2, R2: 10mL×2; 1×1mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073162N
Basic UDI-DI: B-R073162N
Reference: R07316
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-R073152L

R1: 48mL×1, R2: 13mL×1; 1×1mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073152L
Basic UDI-DI: B-R073152L
Reference: R07315
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-R073142J

R1: 37mL×2, R2: 10mL×2; 1×1mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073142J
Basic UDI-DI: B-R073142J
Reference: R07314
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-R073122E

R1:30mL×1 R2:8mL×1；1mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073122E
Basic UDI-DI: B-R073122E
Reference: R07312
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-R073112C

R1:37mL×1 R2:10mL×1；1mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073112C
Basic UDI-DI: B-R073112C
Reference: R07311
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Homocysteine

IVDR_67_LLB_DUB-C_B_KIT_Homocysteine

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961620
Basic UDI-DI: 0405686901388VZ
Reference: 10381040
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Homocysteine (HCY)

IVDR_67_TTN_DUB-C_B_KIT_HCY

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599298
Basic UDI-DI: 0405686901615VM
Reference: 10995606
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S175S3

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S175S3
Basic UDI-DI: B-CNMF000014455-BF-S175S3
Reference: BF-S175
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S174RZ

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S174RZ
Basic UDI-DI: B-CNMF000014455-BF-S174RZ
Reference: BF-S174
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S173RX

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S173RX
Basic UDI-DI: B-CNMF000014455-BF-S173RX
Reference: BF-S173
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S172RV

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S172RV
Basic UDI-DI: B-CNMF000014455-BF-S172RV
Reference: BF-S172
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S171RT

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S171RT
Basic UDI-DI: B-CNMF000014455-BF-S171RT
Reference: BF-S171
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-A074DC

INDICAID® HCY Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A074DC
Basic UDI-DI: B-A074DC
Reference: INDICAID® HCY Rapid Test
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-16T

Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-16T
Basic UDI-DI: B-6-16T
Reference: "REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Homocysteine (HCY)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599304
Basic UDI-DI: 0405686901615VM
Reference: 10995607
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details