Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

17.07.2026 03:09

Sync status

Successful

Device

2834629

Actor

47412

Certificate

3100

Active filter:Manufacturer SRN:US-MF-000016560

410 device results listed.

Page 4 / 21

ADVIA® 560 Lyse

IVDR_67_TTN_DUB-C_A_REAG_Lyse

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414601878
Basic UDI-DI
0405686901744VZ
Reference
11170846
EMDN
W0103010105
EMDN description
CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
ADVIA® 360 Lyse 3P Diff

IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414601281
Basic UDI-DI
0405686901745W3
Reference
11170848
EMDN
W0103010105
EMDN description
CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414599861
Basic UDI-DI
0405686901770W2
Reference
10995673
EMDN
W0102152202
EMDN description
HORMONE STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica IM Rubella IgM Quality Control (Rub M QC)

IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414599847
Basic UDI-DI
0405686901867WJ
Reference
10995669
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica IM Creatine Kinase MB Calibrator (CKMB CAL)

IVDR_67_TTN_DUB-C_C_REAG_CKMB Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414598598
Basic UDI-DI
0405686901905VZ
Reference
10995532
EMDN
W0102152204
EMDN description
CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica IM Calibrator D (CAL D)

IVDR_67_TTN_DUB-C_C_REAG_CAL D

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414598376
Basic UDI-DI
0405686901831VV
Reference
10995510
EMDN
W0102152205
EMDN description
TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica IM CA 15-3 Calibrator (CA15-3 CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 15-3 Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414598147
Basic UDI-DI
0405686901829WA
Reference
10995487
EMDN
W0102152205
EMDN description
TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica IM CA 125II Calibrator (CA 125II CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 125II Cal

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414598109
Basic UDI-DI
0405686901828W8
Reference
10995483
EMDN
W0102152205
EMDN description
TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Toxicology Calibrator (TOX CAL)

IVDR_67_TTN_DUB-C_B_REAG_TOX CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414597614
Basic UDI-DI
0405686901780W5
Reference
11099440
EMDN
W0102152299
EMDN description
STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Chemistry Calibrator (CHEM CAL)

IVDR_67_TTN_DUB-C_C_REAG_Chemistry Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414597492
Basic UDI-DI
0405686901837W9
Reference
11099411
EMDN
W0101050301
EMDN description
CALIBRATORS MULTICOMPONENT (CC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH DRUG CAL (DRUG CAL)

IVDR_67_TTN_DUB-C_B_REAG_DRUG CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414597386
Basic UDI-DI
0405686901697WH
Reference
11099336
EMDN
W0102152201
EMDN description
TDM/DRUG STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)

IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 CAL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414597225
Basic UDI-DI
0405686901704VM
Reference
11099317
EMDN
W0101050301
EMDN description
CALIBRATORS MULTICOMPONENT (CC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Albumin (Alb)

IVDR_67_TTN_DUB-C_B_REAG_ALB_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596501
Basic UDI-DI
0405686901648W4
Reference
11097590
EMDN
W01010201
EMDN description
ALBUMIN (CC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
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
Atellica CH Alanine Aminotransferase (ALT)

IVDR_67_TTN_DUB-C_B_REAG_ALT_c

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596365
Basic UDI-DI
0405686901650VP
Reference
11097605
EMDN
W01010103
EMDN description
ALANINE AMINO-TRANSFERASE
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Uric Acid (UA)

IVDR_67_TTN_DUB-C_B_REAG_UA_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596334
Basic UDI-DI
0405686901791WA
Reference
11097608
EMDN
W01010232
EMDN description
URIC ACID
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Ethyl Alcohol (ETOH)

IVDR_67_TTN_DUB-C_B_REAG_ETOH

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596112
Basic UDI-DI
0405686901708VV
Reference
11097501
EMDN
W0102090207
EMDN description
ETHANOL (ALCOHOL)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Opiates (Op)

IVDR_67_TTN_DUB-C_B_REAG_OP_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596105
Basic UDI-DI
0405686901753W2
Reference
11097502
EMDN
W0102090113
EMDN description
OPIATES
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Cannabinoids THC (Thc)

IVDR_67_TTN_DUB-C_B_REAG_THC_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596099
Basic UDI-DI
0405686901774WA
Reference
11097503
EMDN
W0102090105
EMDN description
CANNABINOIDS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35
Atellica CH Cocaine Metabolite (Coc)

IVDR_67_TTN_DUB-C_B_REAG_Cocaine Metabolite

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414596082
Basic UDI-DI
0405686901687WE
Reference
11097504
EMDN
W0102090106
EMDN description
COCAINE + COCAINE METABOLITES
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:35