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EUDAMED Device Search

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ADVIA Centaur Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414602943
Basic UDI-DI: 0405686901606VL
Reference: 10994924
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

06935784461201

BF S11

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784461201
Basic UDI-DI: B-06935784461201
Reference: BF-S111
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

06935784461003

BF S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784461003
Basic UDI-DI: B-06935784461003
Reference: BF-S011
EMDN: W0102060103
EMDN description: INSULIN
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

06935784460907

BF S02

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460907
Basic UDI-DI: B-06935784460907
Reference: BF-S021
EMDN: W0102060101
EMDN description: C-PEPTIDE
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

06935784460501

BF S20

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460501
Basic UDI-DI: B-06935784460501
Reference: BF-S201
EMDN: W0102069013
EMDN description: PROCALCITONIN
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

25-OH-VD Quantitative Test Kit (Time-Resolved FIA)

FIVD-402a-DR10, FIVD-402a-DR10LH, FIVD-402a-DR10HG, FIVD-402a-DR, FIVD-402a-DRLH, FIVD-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003902
Basic UDI-DI: 69509960FIVD-402a-DRZ9
Reference: FIVD-402a-DR10
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Quantitative Test Kit (Time-Resolved FIA)

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003919
Basic UDI-DI: 69509960FIVD-402a-DRZ9
Reference: FIVD-402a-DR
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

Angiotensin Ⅱ CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359587334
Basic UDI-DI: B-06942359587334
Reference: CMD0501
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 ACTH

IVDR_67_LLB_DUB-C_B_KIT_ACTH

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414960999
Basic UDI-DI: 0405686901362VF
Reference: 10381468
EMDN: W0102060401
EMDN description: ADRENOCORTIOTROPIC HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238692
Basic UDI-DI: 0405686902022UT
Reference: 11354447
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T402aOGST
Basic UDI-DI: B-GDPCT-T402aOGST
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® C-Peptid

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200097
Basic UDI-DI: B-08056771200097
Reference: 316171
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 06:29

Manufacturer products View details

LIAISON® Cortisol

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200080
Basic UDI-DI: B-08056771200080
Reference: 313261
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 06:29

Manufacturer products View details

Atellica IM Insulin (IRI)

IVDR_67_TTN_DUB-C_B_REAG_IRI

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600444
Basic UDI-DI: 0405686900789WG
Reference: 10995628
EMDN: W0102060103
EMDN description: INSULIN
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

Atellica IM Follicle Stimulating Hormone (FSH)

IVDR_67_TTN_DUB-C_B_KIT_FSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599045
Basic UDI-DI: 0405686901612VF
Reference: 10995580
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
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

Atellica IM DHEA-SO4 (DHEAS)

IVDR_67_TTN_DUB-C_B_KIT_DHEAS

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598796
Basic UDI-DI: 0405686901608VQ
Reference: 10995555
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
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

iStar-Gastrin-17

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76346G2
Basic UDI-DI: B-DC76346G2
Reference: DC76346
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Gastrin-17

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76347G4
Basic UDI-DI: B-DC76347G4
Reference: DC76347
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Gastrin-17

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76345FY
Basic UDI-DI: B-DC76345FY
Reference: DC76345
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-hGH

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76338G3
Basic UDI-DI: B-DC76338G3
Reference: DC76338
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details