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241 device results listed.

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Calibrator 8 for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230340
Basic UDI-DI: 1912013223A371-082WG
Reference: A371-082
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

Calibrator 7 for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230326
Basic UDI-DI: 1912013223A371-080WC
Reference: A371-080
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

Calibrator set – Level 0 – 6 for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230180
Basic UDI-DI: 1912013223A371-011VR
Reference: A371-011
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

ISE Reference Solution Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4US3008P
Basic UDI-DI: B-4US3008P
Reference: 4US300
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Reference Solution Serum Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4SS3007Z
Basic UDI-DI: B-4SS3007Z
Reference: 4SS300
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261770
Basic UDI-DI: B-06942202261770
Reference: 232021102013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261763
Basic UDI-DI: B-06942202261763
Reference: 232021002011
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood sample calibrator

Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261503
Basic UDI-DI: B-06942202261503
Reference: 232030412202
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level4: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247293
Basic UDI-DI: B-06942202247293
Reference: 3011950
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level3: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247286
Basic UDI-DI: B-06942202247286
Reference: 3012079
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level2: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247279
Basic UDI-DI: B-06942202247279
Reference: 3011989
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level1: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247262
Basic UDI-DI: B-06942202247262
Reference: 3012148
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemical Calibration Serum

Level2: 4×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235054
Basic UDI-DI: B-06942202235054
Reference: 3025740
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood sample calibrator

Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230899
Basic UDI-DI: B-06942202230899
Reference: 232030412202
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood sample calibrator

Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230882
Basic UDI-DI: B-06942202230882
Reference: 232030412201
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemical Calibration Serum

4x5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229572
Basic UDI-DI: B-06942202229572
Reference: 232030414203
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:58

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood sample calibrator

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226502
Basic UDI-DI: B-06942202226502
Reference: 3024567
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

CORMAY HDL/LDL CALIBRATOR

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651788
Basic UDI-DI: B-05907514651788
Reference: 5-178
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY MULTICALIBRATOR LEVEL 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651771
Basic UDI-DI: B-05907514651771
Reference: 5-177
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY MULTICALIBRATOR LEVEL 1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651764
Basic UDI-DI: B-05907514651764
Reference: 5-176
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details