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747 device results listed.

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MassTrak™ Steroid Serum QC Set 2

IVD Class BIVDR 2017/746On the market

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020551
Basic UDI-DI: 081677602MSTKENDOB5
Reference: 186010564IVD
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

MassTrak™ Steroid Serum QC Set 3

IVD Class BIVDR 2017/746On the market

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020575
Basic UDI-DI: 081677602MSTKENDOB5
Reference: 186010566IVD
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

MassTrak™ Steroid Serum Cal Set 3

IVD Class BIVDR 2017/746On the market

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020568
Basic UDI-DI: 081677602MSTKENDOB5
Reference: 186010565IVD
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

MassTrak™ Endocrine Blank Calibrator

MassTrak™ Endocrine Product Family

IVD Class BIVDR 2017/746On the market

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020247
Basic UDI-DI: 081677602MSTKENDOB5
Reference: 186010560IVD
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrator For Clinical Chemistry

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G45844805003VP
Basic UDI-DI: B-G45844805003VP
Reference: 448 05 003
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrator For Clinical Chemistry

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G45844801003ZN
Basic UDI-DI: B-G45844801003ZN
Reference: 448 01 003
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

OSMOREF®

Reference Solution OSMOREF® 290mOsmol/kg NaCl/H2O

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
Manufacturer SRN: DE-MF-000006548
UDI-DI: 04260341780603
Basic UDI-DI: B-04260341780603
Reference: 30.9.0290
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:58

Manufacturer products View details

04260341780597

IVD generalNot specifiedOn the market

Manufacturer: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
Manufacturer SRN: DE-MF-000006548
UDI-DI: 04260341780597
Basic UDI-DI: B-04260341780597
Reference: 30.9.2000
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:58

Manufacturer products View details

04260341780580

Calibration Standard 850mOsmol/kg NaCl/H2O

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
Manufacturer SRN: DE-MF-000006548
UDI-DI: 04260341780580
Basic UDI-DI: B-04260341780580
Reference: 30.9.0850
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:58

Manufacturer products View details

04260341780573

Calibration Standard 500mOsmol/kg NaCl/H2O

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
Manufacturer SRN: DE-MF-000006548
UDI-DI: 04260341780573
Basic UDI-DI: B-04260341780573
Reference: 30.9.0500
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:58

Manufacturer products View details

04260341780566

Calibration Standard 300mOsmol/kg NaCl/H2O

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: GONOTEC Gesellschaft für Meß- und Regeltechnik mbH
Manufacturer SRN: DE-MF-000006548
UDI-DI: 04260341780566
Basic UDI-DI: B-04260341780566
Reference: 30.9.0020
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:58

Manufacturer products View details