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174 device results listed.

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Atellica CH Bilirubin Calibrator (BILI CAL)

IVDR_67_TTN_DUB-C_C_REAG_BILI CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414615097
Basic UDI-DI: 0405686902241V9
Reference: 11537243
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH ENZ 3 Calibrator (ENZ 3 CAL)

IVDR_67_TTN_DUB-C_C_REAG_ENZ 3 CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597249
Basic UDI-DI: 0405686901706VR
Reference: 11099319
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL)

IVDR_67_TTN_DUB-C_B_REAG_UCFP CAL

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414279190
Basic UDI-DI: 0405686901793WE
Reference: 11099339
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® ALDL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_ALDL CAL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014093
Basic UDI-DI: 0405686901058V9
Reference: 10444996
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Total Iron Binding Capacity (IBCT) Calibrator

IVDR_67_GLA_DUB-C_B_REAG_IBCT CAL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005206
Basic UDI-DI: 0405686901123UT
Reference: 10445006
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL)

IVDR_67_TTN_DUB-C_B_REAG_ALP_2_Cal

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597218
Basic UDI-DI: 0405686900762VU
Reference: 11099316
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Albumin BCP Calibrator (AlbP CAL)

IVDR_67_TTN_DUB-C_B_REAG_ALBP_Cal

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597201
Basic UDI-DI: 0405686900761VS
Reference: 11099310
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Prealbumin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_PALB_cal

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005183
Basic UDI-DI: 0405686900206UR
Reference: 10445025
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E Standard

IS0246

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02469A
Basic UDI-DI: B-IS02469A
Reference: IS0246
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Antistreptolisin O

IS0241

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02418Y
Basic UDI-DI: B-IS02418Y
Reference: IS0241
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Fibrinogen‐ONE Calibrator

IS02295

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02295N6
Basic UDI-DI: B-IS02295N6
Reference: IS02295
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Specific Proteins Multicalibrator

IS0227

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS022796
Basic UDI-DI: B-IS022796
Reference: IS0227
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:40

Manufacturer products View details

Cystatin C Standard

IS0203

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02038Q
Basic UDI-DI: B-IS02038Q
Reference: IS0203
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:40

Manufacturer products View details

ULK (Urine Kappa and Lambda) Calibrator

IS01ULK

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS01ULKW9
Basic UDI-DI: B-IS01ULKW9
Reference: IS01ULK
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:40

Manufacturer products View details

Microalbumin Calibrator

IS01274

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS01274MP
Basic UDI-DI: B-IS01274MP
Reference: IS01274
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:40

Manufacturer products View details

TOTAL HEMOGLOBIN

CS02385

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-CS02385K2
Basic UDI-DI: B-CS02385K2
Reference: CS02385
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 13.07.2026 07:20

Manufacturer products View details

CALIBRATORE HDL/LDL

FCC40-1-2

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: FUTURLAB S.R.L.
Manufacturer SRN: IT-MF-000046539
UDI-DI: D-CALIBRATORE-HDL-LDLND
Basic UDI-DI: B-CALIBRATORE-HDL-LDLND
Reference: FCC40-1-2
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 13.07.2026 03:55

Manufacturer products View details

HbA1c, Frozen Whole Blood

HbA1c, Frozen Whole Blood, Level Low

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: D-87205897082359Z
Basic UDI-DI: B-87205897082359Z
Reference: HBAFr-03.1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:26

Manufacturer products View details

HbA1c, Frozen Whole Blood

HbA1c, Frozen Whole Blood, Level High

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: D-87205897082429W
Basic UDI-DI: B-87205897082429W
Reference: HBAFr-03.3
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:26

Manufacturer products View details

HbA1c, ingevroren volbloed Level 2

HbA1c, ingevroren volbloed

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: 87205897082286
Basic UDI-DI: B-87205897082286
Reference: HBAFr-01.2
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:22

Manufacturer products View details