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IGFBP-1 Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD142XE
Basic UDI-DI: B-GKPD142XE
Reference: GKPD142
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette (Whole Blood)

GIVD-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GIVD-402aHGX3
Basic UDI-DI: B-GIVD-402aHGX3
Reference: GIVD-402a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GH Growth hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-GH706-AEZ5
Basic UDI-DI: B-GH706-AEZ5
Reference: GH706-AE10Y, GH706-AE10N, GH706-AE20Y, GH706-AE20N
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:36

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: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDPCT-T402aHGS6
Basic UDI-DI: B-GDPCT-T402aHGS6
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

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 marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T402aC6
Basic UDI-DI: B-GDPCT-T402aC6
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

GDPCT-T401a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T401aC3
Basic UDI-DI: B-GDPCT-T401aC3
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-402a5B
Basic UDI-DI: B-GDPCT-402a5B
Reference: GDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

GDF-15 Growth Differentiation Factor-15 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-GDF-15706-AEQU
Basic UDI-DI: B-GDF-15706-AEQU
Reference: GDF-15706-AE10Y, GDF-15706-AE10N, GDF-15706-AE20Y, GDF-15706-AE20N
EMDN: W0102060499
EMDN description: ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Cassette (Swab)

GAIGF1-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GAIGF1-502aL2
Basic UDI-DI: B-GAIGF1-502aL2
Reference: GAIGF1-502a
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Cassette (Swab)

GAIGF1-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GAIGF1-502aHGPY
Basic UDI-DI: B-GAIGF1-502aHGPY
Reference: GAIGF1-502a
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Strip (Cervical Secretion)

GAIGF1-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GAIGF1-501aKX
Basic UDI-DI: B-GAIGF1-501aKX
Reference: GAIGF1-501a
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Strip (Swab)

GAIGF1-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GAIGF1-501aHGPR
Basic UDI-DI: B-GAIGF1-501aHGPR
Reference: GAIGF1-501a
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

G-17 Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-G-17706-AEK6
Basic UDI-DI: B-G-17706-AEK6
Reference: G-17706-AE10Y, G-17706-AE10N, G-17706-AE20Y, G-17706-AE20N
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Intact Parathyroid Hormone (PTH)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599458
Basic UDI-DI: 0405686901625VQ
Reference: 10995622
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Progesterone (PRGE)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599786
Basic UDI-DI: 0405686901624VN
Reference: 10995660
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prolactin (PRL)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599748
Basic UDI-DI: 0405686901623VL
Reference: 10995656
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BRAHMS Procalcitonin (PCT)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246550
Basic UDI-DI: 0405686901818W5
Reference: 11202699
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Progesterone (PRGE)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599779
Basic UDI-DI: 0405686901624VN
Reference: 10995659
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prolactin (PRL)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599731
Basic UDI-DI: 0405686901623VL
Reference: 10995655
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Intact Parathyroid Hormone (PTH)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599441
Basic UDI-DI: 0405686901625VQ
Reference: 10995621
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details