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AutoChem HPT

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253010372
Basic UDI-DI: B-06942253010372
Reference: 360111HPT000S
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem TRF

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253010105
Basic UDI-DI: B-06942253010105
Reference: 360106TRF000S
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

p63

CM163A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006554
Basic UDI-DI: B-00847627006554
Reference: CM163A
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 21.07.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Immunoglobulin A Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IGA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005688
Basic UDI-DI: 0405686901124UV
Reference: 10444982
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Immunoglobulin G Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IGM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005701
Basic UDI-DI: 0405686901126UZ
Reference: 10444983
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

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IMMULITE 2000 FSH

IVDR_67_LLB_DUB-C_B_REAG_KIT_follicle stimulating hor

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961514
Basic UDI-DI: 0405686901382VM
Reference: 10381180
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

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IMMULITE 2000 DHEA-SO4

IVDR_67_LLB_DUB-C_B_REAG_KIT_DHEA-SO4

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961309
Basic UDI-DI: 0405686901376VS
Reference: 10381193
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 LH

IVDR_67_LLB_DUB-C_B_REAG_Luteinizing Hormone

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961699
Basic UDI-DI: 0405686901434VF
Reference: 10381211
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-1 SP-24 Kit

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013008996
Basic UDI-DI: 5056013005BANDM8
Reference: 200100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-1 SP-24 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013009009
Basic UDI-DI: 5056013005BANDM8
Reference: 200100H
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-3 SP-60 Kit

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013010517
Basic UDI-DI: 5056013005BANDM8
Reference: 300100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 600 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011538
Basic UDI-DI: 5056013005BANDM8
Reference: 3145
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 300 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011552
Basic UDI-DI: 5056013005BANDM8
Reference: 3146
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 180 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011569
Basic UDI-DI: 5056013005BANDM8
Reference: 3147
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN Immuno Turbidimetry

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesInstrumentKit

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182724030
Basic UDI-DI: B-62230182724030
Reference: D-859 001
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

06935784400286

1 Test/Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784400286
Basic UDI-DI: B-06935784400286
Reference: COM-S0101E0
EMDN: W0102019005
EMDN description: FIBRONECTIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

Antiserum to Human C1-Inhibitor

IVDR_27_MAR EB_B_REAG_AS_C1_In

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414238319
Basic UDI-DI: 0405686902150V5
Reference: 10873657
EMDN: W0102010202
EMDN description: COMPLEMENT COMPONENT C1 INHIBITOR
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 23:43

Manufacturer products View details

IMMULITE 2000 Total Testosterone

IVDR_67_LLB_DUB-C_B_REAG_KIT_Total Testosterone

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962221
Basic UDI-DI: 0405686901414V9
Reference: 10381191
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Progesterone

IVDR_67_LLB_DUB-C_B_KIT_Progestrne

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961972
Basic UDI-DI: 0405686901401UY
Reference: 10381181
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S225RR

BF S22

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-S225RR
Basic UDI-DI: B-CNMF000014455-BF-S225RR
Reference: BF-S225
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details