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EUDAMED Device Search

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

Last updated

24.09.2026 15:16

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Device

3609459

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Certificate

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Active filter:Manufacturer SRN:US-MF-000016560

877 device results listed.

Page 27 / 44

Atellica CH Urine Albumin Calibrator (UAlb CAL)

IVDR_67_TTN_DUB-C_B_REAG_UAlb CAL

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414611204
Basic UDI-DI
0405686902319VM
Reference
11537247
EMDN
W0102152203
EMDN description
SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Urine Albumin (UAlb)

IVDR_67_TTN_DUB-C_B_REAG_UALb

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414611099
Basic UDI-DI
0405686902318VK
Reference
11537225
EMDN
W0102010309
EMDN description
ALBUMIN (IC) INCL. UALBUMIN
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Total Protein_2 (TP_2)

IVDR_67_TTN_DUB-C_B_REAG_TP_2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414611082
Basic UDI-DI
0405686902305VA
Reference
11537228
EMDN
W01010230
EMDN description
TOTAL PROTEIN
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Creatinine_3 (Crea3)

IVDR_67_LLB_DUB-C_C_REAG_Crea3

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414611075
Basic UDI-DI
0405686902344VL
Reference
11537215
EMDN
W01010207
EMDN description
CREATININE
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Protein 2 Calibrator (PROT2 CAL)

IVDR_67_TTN_DUB-C_C_REAG_PROT2 CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414611051
Basic UDI-DI
0405686902331VB
Reference
11537246
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 00:36
Atellica CH Haptoglobin_2 (Hapt_2)

IVDR_67_TTN_DUB-C_B_REAG_Hapt_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414610986
Basic UDI-DI
0405686902249VR
Reference
11537232
EMDN
W0102010302
EMDN description
HAPTOGLOBIN
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Lactate_3 (Lac_3)

IVDR_67_LLB_DUB-C_B_REAG_Lac_3

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414610979
Basic UDI-DI
0405686902343VJ
Reference
11537218
EMDN
W01010218
EMDN description
LACTATE
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Enzymatic Creatinine_3 (ECre3)

IVDR_67_TTN_DUB-C_C_REAG_ECre3

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414610948
Basic UDI-DI
0405686902304V8
Reference
11537216
EMDN
W01010207
EMDN description
CREATININE
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Anti-Streptolysin-O_3 (ASO_3)

IVDR_67_TTN_DUB-C_B_REAG_ASO_3

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414610856
Basic UDI-DI
0405686902306VC
Reference
11537212
EMDN
W01021104
EMDN description
ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
Atellica CH Iron3 (Iron3)

IVDR_67_TTN_DUB-C_B_REAG_Iron3

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414610849
Basic UDI-DI
0405686902345VN
Reference
11537211
EMDN
W0102070106
EMDN description
IRON (IC)
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414608273
Basic UDI-DI
0405686902362VN
Reference
11538186
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 00:36
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414602899
Basic UDI-DI
0405686901861W6
Reference
10994359
EMDN
W0102152004
EMDN description
CARDIAC MARKER CONTROLS
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:36
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