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377 device results listed.

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IDS-iSYS Insulin-like Growth Factor-I (IGF-I)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690288
Basic UDI-DI: B-05060169690288
Reference: IS-3900
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS CTX-I (CrossLaps®) Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690257
Basic UDI-DI: B-05060169690257
Reference: IS-3030
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS N-MID® Osteocalcin Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690233
Basic UDI-DI: B-05060169690233
Reference: IS-2930
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Ostase® BAP Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690219
Basic UDI-DI: B-05060169690219
Reference: IS-2830
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Lumipulse pTau 217 Plasma Controls <2x2C, CE>

81546

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815463
Basic UDI-DI: 54144700375H
Reference: 81546
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

Serum Amyloid A Protein Control

1×1.0mL（Control 1）

IVD Class CIVDR 2017/746On the marketDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098911
Basic UDI-DI: 6970493090506005NZ
Reference: MY-0006-01
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Control

1×1.0mL（Control 1）

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097174
Basic UDI-DI: 6970493090506002NT
Reference: MY-0003-02
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP/Osteocalcin/β-CTx Multi Control

105-045127-00、105-045128-00、105-045130-00 、105-045129-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074087
Basic UDI-DI: 69449040AB74000645W
Reference: 105-045130-00
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Control

105-020947-00、105-021028-00、105-021029-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053029469
Basic UDI-DI: 69449040007C-SAACalCon*6S
Reference: 105-021029-00
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

CHI3L1 Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737834
Basic UDI-DI: 692591270350HF
Reference: CC1018
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Gastrin-17 Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737759
Basic UDI-DI: 692591270335HK
Reference: CC1010
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737742
Basic UDI-DI: 692591270318HK
Reference: CC1009
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Protein Normal Control

CE Serum Protein Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025788
Basic UDI-DI: 505601300ULTCESPCONTTU
Reference: V110
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

Immunotyping Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025801
Basic UDI-DI: 505601300ULTCEIDCONTKN
Reference: V150
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216615
Basic UDI-DI: 50552732BLSPC1218199
Reference: PS3151
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)

APOLIPOPROTEIN CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209105
Basic UDI-DI: 50552732BAPOCON016EE
Reference: LE5016
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

NESCAUTO Cp Auto Control

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

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126833
Basic UDI-DI: 4987274W0102152003CPC00UE
Reference: 912683
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

OC-FCa Control LV3

OC-FCa Reagent Family

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026182360
Basic UDI-DI: 4987026TD-OCFCYC
Reference: V-PH15
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S anti-Tgn/-TPOn KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632264
Basic UDI-DI: 426015763853BaTgTPKQCXX54
Reference: 085392N
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S TRAK human KRYPTOR QC

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630598
Basic UDI-DI: 426015763801BTRAKhKQCXX2X
Reference: 080192N
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details