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275 device results listed.

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VALIDATE® THY Test Set

901bc

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135174
Basic UDI-DI: B-00850011135174
Reference: 901bc
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

Analyzer (automatic and non-automatic)

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050003
Basic UDI-DI: 697492505000001T4
Reference: BYZKA0101
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 17:44

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Control

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

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815184
Basic UDI-DI: 697388081057PD
Reference: ZCC043
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

GBM IgG Control

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

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815153
Basic UDI-DI: 697388081054P7
Reference: ZCC038
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Inhibin B Control

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815146
Basic UDI-DI: 697388081052P3
Reference: ZCC028
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

17α-Hydroxyprogesterone Control

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813333
Basic UDI-DI: 697388081033NX
Reference: ZCC093
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Control

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

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813142
Basic UDI-DI: 697388081021NQ
Reference: ZCC051
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

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

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812909
Basic UDI-DI: 697388081001NJ
Reference: ZCC027
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Progesterone (CLIA) Controls

Progesterone (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145586294
Basic UDI-DI: 694714551049JA
Reference: 1602011049MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Testosterone (CLIA) Controls

Testosterone (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145586218
Basic UDI-DI: 694714551047J6
Reference: 1602011047MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Androstenedione (CLIA) Controls

Androstenedione (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548322
Basic UDI-DI: 694714551052HX
Reference: 1602011052MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Unconjugated Estriol (CLIA) Controls

Unconjugated Estriol (CLIA) Controls

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529123
Basic UDI-DI: 69471455260W3
Reference: 160201260MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-TM (CLIA) Controls

Anti-TM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515645
Basic UDI-DI: 69471455248WD
Reference: 160201248MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Androstenedione (CLIA) Controls

Androstenedione (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515195
Basic UDI-DI: 69471455423W7
Reference: 160201423MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Free T4 (CLIA) Controls

Free T4 (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580841
Basic UDI-DI: 694714551042HU
Reference: 1602011042MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Free T3 (CLIA) Controls

Free T3 (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580803
Basic UDI-DI: 694714551041HS
Reference: 1602011041MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Total T4 (CLIA) Controls

Total T4 (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580766
Basic UDI-DI: 694714551040HQ
Reference: 1602011040MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Total T3 (CLIA) Controls

Total T3 (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580728
Basic UDI-DI: 694714551039J7
Reference: 1602011039MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

06950617424741

EIM4498300 EIM4497300 EIM4496300 EIM4495300 EIM4494300 EIM4493300 EIM4492300 EIM4491300 EIM4490300 EIM4499202 EIM4498202 EIM4497202 EIM4496202 EIM4495202 EIM4494202 EIM4493202 EIM4492202 EIM4491202

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617424741
Basic UDI-DI: 69506174IM449202EZ
Reference: EIM4497300
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

06950617424734

EIM4498300 EIM4497300 EIM4496300 EIM4495300 EIM4494300 EIM4493300 EIM4492300 EIM4491300 EIM4490300 EIM4499202 EIM4498202 EIM4497202 EIM4496202 EIM4495202 EIM4494202 EIM4493202 EIM4492202 EIM4491202

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617424734
Basic UDI-DI: 69506174IM449202EZ
Reference: EIM4491202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details