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EUDAMED Device Search

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Cortisol (COR) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrFCOR8037D
Basic UDI-DI: B-acrFCOR8037D
Reference: acrFCOR803
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol (COR) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrFCOR8027B
Basic UDI-DI: B-acrFCOR8027B
Reference: acrFCOR802
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

ReFiNE® Dkk3 ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598012714
Basic UDI-DI: 4050598DVPhysParaTV
Reference: Y1001
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 23:20

Manufacturer products View details

Parathyroid Hormone (PTH) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OPT-ACO402FG
Basic UDI-DI: B-OPT-ACO402FG
Reference: OPT-ACO402
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458399002STU5
Basic UDI-DI: B-G458399002STU5
Reference: 399 002
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.08.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458399001STP5
Basic UDI-DI: B-G458399001STP5
Reference: 399 001
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.08.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

PTH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-PTH-402VP
Basic UDI-DI: B-ACO-PTH-402VP
Reference: ACO-PTH-402
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300021BUN
Basic UDI-DI: B-300021BUN
Reference: HU-RE-F07F046001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300015BUV
Basic UDI-DI: B-300015BUV
Reference: HU-RE-F07F032001
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490503
Basic UDI-DI: B-06975679490503
Reference: HU-RE-F07F032002
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490466
Basic UDI-DI: B-06975679490466
Reference: HU-RE-F07F046002
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490404
Basic UDI-DI: B-06975679490404
Reference: HU-RE-F08F027002
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983169905
Basic UDI-DI: B-06936983169905
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858885
Basic UDI-DI: B-06933289858885
Reference: WA26P0006
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858878
Basic UDI-DI: B-06933289858878
Reference: WA26P0005
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858861
Basic UDI-DI: B-06933289858861
Reference: WA26P0004
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858854
Basic UDI-DI: B-06933289858854
Reference: WA26P0003
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858564
Basic UDI-DI: B-06933289858564
Reference: WA05P0004
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858557
Basic UDI-DI: B-06933289858557
Reference: WA05P0003
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858540
Basic UDI-DI: B-06933289858540
Reference: WA05P0002
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details