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Tube Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825029
Basic UDI-DI: 69503348MTA006LT
Reference: 62005002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Tube Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825012
Basic UDI-DI: 69503348MTA005LR
Reference: 62014001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Solution

2 × 250 T/Kit, 2 × 100 T/Kit , 2 × 500 T/Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825005
Basic UDI-DI: 69503348MTA004LP
Reference: 62031001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Concentrated Wash Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334824992
Basic UDI-DI: 69503348MTA003LM
Reference: 62020001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST Presepsin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301254
Basic UDI-DI: 4987595PF1201KX3
Reference: 30125
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

DNlite uPTM-FetA ELISA Kit – 10x Wash Buffer

8105003

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879495027
Basic UDI-DI: 471987949E103077W
Reference: 8105003
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Antigen Retrieval 2 (AR2), low pH

Oncore Pro Antigen Retrieval Systems

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031853
Basic UDI-DI: 08476270BOPAGRETYX
Reference: OPRI6005T60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Dewax Solution Kit

Dewaxing Reagents of IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031846
Basic UDI-DI: 08476270BDEWAXH2
Reference: OPRI6004KT60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

07640146270207

TECO® Intact proinsulin ELISA wash solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: TECOmedical AG
Manufacturer SRN: CH-MF-000030341
UDI-DI: 07640146270207
Basic UDI-DI: 0764014627TE1112QC
Reference: TE1112
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: EUROBIO SCIENTIFIC
Last updated: 16.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000/XPi Probe Cleaning Kit

IVDR_27_MAR EB_A_REAG_IMM_Probe_Cl

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768028434
Basic UDI-DI: 0405686902050UY
Reference: 10385229
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

IMMULITE 2000/XPi Probe Wash Module

IVDR_27_MAR EB_A_IMM_Probe_Wa

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768028427
Basic UDI-DI: 0405686902051V2
Reference: 10385231
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

BN II Additive

IVDR_27_MAR EB_A_REAG_BNII_Add

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007781
Basic UDI-DI: 0405686902052V4
Reference: 10446098
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:37

Manufacturer products View details

Atellica IM Vitamin D Total II Diluent (VitDII DIL)

IVDR_67_TTN_DUB-C_A_REAG_VitDII Dil

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414649979
Basic UDI-DI: 0405686902370VM
Reference: 11698630
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NfL Diluent (NfL DIL)

IVDR_67_TTN_DUB-C_C_REAG_SNFL DIL ANCPK 2PK

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414635484
Basic UDI-DI: 0405686902258VS
Reference: 11562428
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Base

IVDR_67_TTN_DUB-C_A_REAG_Base

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414613437
Basic UDI-DI: 0405686902148VJ
Reference: 11417930
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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 IM Acid

IVDR_67_TTN_DUB-C_A_REAG_Acid

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414613239
Basic UDI-DI: 0405686902147VG
Reference: 11417929
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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 IM aTPOII Diluent (aTPOII DIL)

IVDR_67_LLB_DUB-C_A_REAG_aTPOII DIL

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414609492
Basic UDI-DI: 0405686902270VG
Reference: 11207637
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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

ADVIA Centaur® FOL DTT/Releasing Agent

IVDR_67_TTN_DUB-C_B_REAG_Folate DTT / Releasing Agent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451060
Basic UDI-DI: 0405686901709VX
Reference: 10310382
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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

ADVIA Centaur® T3/T4/VB12 Ancillary Reagent

IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175379
Basic UDI-DI: 0405686901772W6
Reference: 10319315
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CKMB Diluent

IVDR_67_TTN_DUB-C_A_REAG_CKMB Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175324
Basic UDI-DI: 0405686901902VT
Reference: 10309951
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details