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211 device results listed.

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PCT Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104784
Basic UDI-DI: 6970277510014LYJ
Reference: CPC-N402-10
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104760
Basic UDI-DI: 6970277510000XYR
Reference: CPC-N302-10
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Rapid Quantitative Test (Fluorescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260211777
Basic UDI-DI: B-06933260211777
Reference: BT2213
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06935784461300

BF S26

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784461300
Basic UDI-DI: B-06935784461300
Reference: BF-S261
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
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

06935784460600

BF S16

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460600
Basic UDI-DI: B-06935784460600
Reference: BF-S161
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
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

TSH Quantitative Test Kit (Time-Resolved FIA)

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

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: 06950996003841
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DR10
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

TSH 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: 06950996003858
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DR
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
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

TSH 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: 06950996013130
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DRHG
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
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

D-CNMF000014455-BF-S265S5

BF S26

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-S265S5
Basic UDI-DI: B-CNMF000014455-BF-S265S5
Reference: BF-S265
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S264S3

BF S26

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-S264S3
Basic UDI-DI: B-CNMF000014455-BF-S264S3
Reference: BF-S264
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S263RZ

BF S26

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-S263RZ
Basic UDI-DI: B-CNMF000014455-BF-S263RZ
Reference: BF-S263
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
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

D-CNMF000014455-BF-S262RX

BF S26

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-S262RX
Basic UDI-DI: B-CNMF000014455-BF-S262RX
Reference: BF S26
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
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

D-CNMF000014455-BF-S165RY

BF S16

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-S165RY
Basic UDI-DI: B-CNMF000014455-BF-S165RY
Reference: BF-S165
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
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-S164RW

BF S16

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-S164RW
Basic UDI-DI: B-CNMF000014455-BF-S164RW
Reference: BF-S164
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
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-S163RU

BF S16

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-S163RU
Basic UDI-DI: B-CNMF000014455-BF-S163RU
Reference: BF-S163
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
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-S162RS

BF S16

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-S162RS
Basic UDI-DI: B-CNMF000014455-BF-S162RS
Reference: BF-S162
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
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

Procalcitonin Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M17C2ZG
Basic UDI-DI: B-5M17C2ZG
Reference: 5M17C2-25-EU, 5M17C2-50-EU
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5C07C1VR
Basic UDI-DI: B-5C07C1VR
Reference: 5C07C1-25-EU, 5C07C1-50-EU
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Total Thyroxine Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5B05C1V4
Basic UDI-DI: B-5B05C1V4
Reference: 5B05C1-25-EU, 5B05C1-50-EU
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Total Triiodothyronine Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5B04C1UX
Basic UDI-DI: B-5B04C1UX
Reference: 5B04C1-25-EU, 5B04C1-50-EU
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details