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859 device results listed.

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IgE-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170523
Basic UDI-DI: B-08431673170523
Reference: 1107052
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

FERR-CAL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170424
Basic UDI-DI: B-08431673170424
Reference: 1107042
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

ß2-m-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170325
Basic UDI-DI: B-08431673170325
Reference: 1107032
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

Lp(a)-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170226
Basic UDI-DI: B-08431673170226
Reference: 1107022
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

ASO-CAL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170127
Basic UDI-DI: B-08431673170127
Reference: 1107012
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

RF-CAL

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170073
Basic UDI-DI: B-08431673170073
Reference: 1107007
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

CRP-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170028
Basic UDI-DI: B-08431673170028
Reference: 1107002
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

PROT-CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120047
Basic UDI-DI: B-08431673120047
Reference: 1102004
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

PROT-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120030
Basic UDI-DI: B-08431673120030
Reference: 1102003
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

CALPRO-CAL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673015343
Basic UDI-DI: B-08431673015343
Reference: 1107092
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:15

Manufacturer products View details

Dimension Mass Creatine Kinase MB Isoenzyme Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MMB CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013706
Basic UDI-DI: 0405686901281VE
Reference: 10445023
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol Negative Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Cals and Controls

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001970
Basic UDI-DI: 0405686901108UX
Reference: 10445445
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator B Level 1 (cutoff)

IVDR_67_GLA_DUB-C_B_REAG_Cal B Lev 1 (cutoff) Lev 2 (high)

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001796
Basic UDI-DI: 0405686901071UZ
Reference: 10445412
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM C-peptide Calibrator (CpS CAL)

IVDR_67_TTN_DUB-C_B_REAG_C-Peptide Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600420
Basic UDI-DI: 0405686901691W5
Reference: 10995542
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cyclosporine Calibrator (CsA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CsA Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598734
Basic UDI-DI: 0405686901841VY
Reference: 10995549
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Lipoprotein(a) Calibrator (Lp(a) CAL)

IVDR_67_TTN_DUB-C_B_REAG_LPA CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597546
Basic UDI-DI: 0405686901742VV
Reference: 11099433
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH DRUG CAL II (DRUG CAL II)

IVDR_67_TTN_DUB-C_C_REAG_DRUG CAL II

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597485
Basic UDI-DI: 0405686901850VZ
Reference: 11099405
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI High Sensitivity Troponin I Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TNIH_Cal

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414180380
Basic UDI-DI: 0405686900217UW
Reference: 10719483
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol Low Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001987
Basic UDI-DI: 0405686901108UX
Reference: 10445447
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol High Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002007
Basic UDI-DI: 0405686901108UX
Reference: 10445449
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details