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Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL)

IVDR_67_TTN_DUB-C_B_REAG_RCRP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611297
Basic UDI-DI: 0405686902329VQ
Reference: 11537245
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica LumIQ Module

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414642444
Basic UDI-DI: 0405686901935WA
Reference: 11646260
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM AMH Master Curve Material (AMH MCM)

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768022395
Basic UDI-DI: 0405686902268VV
Reference: 10998431
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Cortisol

IVDR_67_LLB_DUB-C_B_KIT_Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961194
Basic UDI-DI: 0405686901374VN
Reference: 10381480
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Inorganic Phosphorus (IP)

IVDR_67_TTN_DUB-C_B_REAG_IP_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596303
Basic UDI-DI: 0405686901733VU
Reference: 11097611
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti‑Müllerian Hormone (AMH)

IVDR_67_TTN_DUB-C_C_CDx_REAG_KIT_AMH

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414225692
Basic UDI-DI: 0405686902266VR
Reference: 10998432
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Diazo Total Bilirubin (D_TBil)

IVDR_67_TTN_DUB-C_B_REAG_D_Tbil

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414614922
Basic UDI-DI: 0405686902240V7
Reference: 11537220
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display Non-Connected

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657196
Basic UDI-DI: 0405686901935WA
Reference: 11702307
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Solution Display

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414640778
Basic UDI-DI: 0405686901935WA
Reference: 11645015
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Solution Display

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414640785
Basic UDI-DI: 0405686901935WA
Reference: 11645018
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti‑Müllerian Hormone (AMH)

IVDR_67_TTN_DUB-C_C_CDx_REAG_KIT_AMH

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768022401
Basic UDI-DI: 0405686902266VR
Reference: 10998433
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Phenobarbital Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Phenobarbital Calibrators

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017414
Basic UDI-DI: 0405686901160UZ
Reference: 10445307
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Cortisol

IVDR_67_LLB_DUB-C_B_KIT_Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961187
Basic UDI-DI: 0405686901374VN
Reference: 10381476
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM DHEAS2

IVDR_67_TTN_DUB-C_B_REAG_KIT_DHEAS2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414632926
Basic UDI-DI: 0405686902311V5
Reference: 11209193
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CsA PRE

IVDR_67_TTN_DUB-C_C_REAG_CsA Pretreatment Reagent

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598765
Basic UDI-DI: 0405686901842W2
Reference: 10995552
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Lactate Dehydrogenase L‑P (LDLP)

IVDR_67_TTN_DUB-C_B_REAG_LDLP

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596464
Basic UDI-DI: 0405686901736W2
Reference: 11097594
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator B

IVDR_67_TTN_DUB-C_C_REAG_Cal B

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414504773
Basic UDI-DI: 0405686901830VT
Reference: 10331729
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur HCY Diluent

IVDR_67_TTN_DUB-C_A_REAG_HCY Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414468211
Basic UDI-DI: 0405686901560VM
Reference: 10318677
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur CA 125II Calibrator

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: 00630414461335
Basic UDI-DI: 0405686901828W8
Reference: 10310444
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur AMH Master Curve Material (AMH MCM)

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414225685
Basic UDI-DI: 0405686902268VV
Reference: 10998430
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details