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190 device results listed.

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β-Hydroxybutyrate (BHB) Calibrator Kit

β-Hydroxybutyrate Calibrator Kit

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Diazyme Laboratories, Inc.
Manufacturer SRN: US-MF-000025166
UDI-DI: 00817089023161
Basic UDI-DI: 0817089023162XA
Reference: DZ153A-CAL
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

β-Hydroxybutyrate Calibrator Kit

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Diazyme Laboratories, Inc.
Manufacturer SRN: US-MF-000025166
UDI-DI: 00817089023826
Basic UDI-DI: 0817089023162XA
Reference: 10581964190
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 10.08.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

04560189283640

Hemoglobin A1c Calibrator Set

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189283640
Basic UDI-DI: B-04560189283640
Reference: 0018767
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 07.08.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

04562185403060

HbA1c Calibrator Set (S)

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185403060
Basic UDI-DI: B-04562185403060
Reference: 0023502
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 07.08.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

04562185403107

G8 HbA1c Calibrator Set (S)

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185403107
Basic UDI-DI: B-04562185403107
Reference: 0023528
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 07.08.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Enzymatic Hemoglobin A1c_E Calibrator (A1c_E CAL)

IVDR_67_TTN_DUB-C_C_REAG_A1c_E_Cal

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220512
Basic UDI-DI: 0405686900755VX
Reference: 11099338
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Cholinesterase_2 (CHE_2)

IVDR_67_TTN_DUB-C_B_REAG_CHE_2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611044
Basic UDI-DI: 0405686902248VP
Reference: 11537221
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

5'-NT Calibrator

105-003176-00、105-003119-00、105-003124-00、105-026281-00、105-026282-00、105-026283-00、105-020475-00、105-003688-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037868
Basic UDI-DI: 6944904000435-NT*******ZV
Reference: 105-003688-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

ADA Calibrator

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037851
Basic UDI-DI: 694490400043ADA********WS
Reference: 105-003687-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

CHOLESTEROL LDL 2G CALIBRATOR

LDLL-0011

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700824510
Basic UDI-DI: B-03701700824510
Reference: LDLL-0011
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

CHOLESTEROL LDL 2G CALIBRATOR

LDLL-0041

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700824503
Basic UDI-DI: B-03701700824503
Reference: LDLL-0041
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

CHOLESTEROL HDL 2G CALIBRATOR

HDLL-0011

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821410
Basic UDI-DI: B-03701700821410
Reference: HDLL-0011
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

CHOLESTEROL HDL 2G CALIBRATOR

HDLL-0041

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821403
Basic UDI-DI: B-03701700821403
Reference: HDLL-0041
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

BILIRUBIN T CALIBRATOR

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673022501
Basic UDI-DI: B-08431673022501
Reference: 1002250
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:15

Manufacturer products View details

06941967218975

IVD Class BNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218975
Basic UDI-DI: 697326286001982R
Reference: 01.09.1F.01.10.03
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 03.08.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

CORMAY CK-MB CALIBRATOR

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651825
Basic UDI-DI: B-05907514651825
Reference: 5-182
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY URINE PROTEINS CALIBRATORS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651818
Basic UDI-DI: B-05907514651818
Reference: 5-181
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY HbA1c DIRECT CALIBRATORS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514643080
Basic UDI-DI: B-05907514643080
Reference: 4-308
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:05

Manufacturer products View details

HbA1c Calibrator

HT001S

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101711
Basic UDI-DI: B-05404035101711
Reference: HT001S
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

Hemoglobin Calibrator

HBS02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101629
Basic UDI-DI: B-05404035101629
Reference: HBS02
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details