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06921893025427

NRM-FI-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893025427
Basic UDI-DI: 69218930001004V
Reference: 12000002900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica LumIQ Module

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: 00630414642406
Basic UDI-DI: 0405686901935WA
Reference: 11646259
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 23:17

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

CS-2000i

CS-2000 CS-2000i

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520012
Basic UDI-DI: 69257945W0201010104D0JW
Reference: 3012225
EMDN: W0201010104
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 10.08.2026 21:59

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CS-2000

IVD Class ANot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520029
Basic UDI-DI: 69257945W0201010104D0JW
Reference: 3014142
EMDN: W0201010104
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 10.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

CS-1300B

IVD Class ANot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576125
Basic UDI-DI: 69257945W0201010103D0JR
Reference: 3001454
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 10.08.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

CS-2000

IVD Class ANot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576187
Basic UDI-DI: 69257945W0201010104D0JW
Reference: 3012227
EMDN: W0201010104
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 10.08.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001735

NRM411

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001735
Basic UDI-DI: 69218930057077C
Reference: 12000001100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862638

Surearly SMART App

IVD Class BIVDR 2017/746On the marketInstrumentSelf testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862638
Basic UDI-DI: 88094088SSMA-001A9
Reference: SSMA001E
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 08.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862591

Surearly SMART

IVD Class BIVDR 2017/746On the marketInstrumentSelf testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862591
Basic UDI-DI: 88094088SSM-001Y2
Reference: SSMD001E
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 08.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

Chromatographic Column(HPLC)

GH-900Plus

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680497
Basic UDI-DI: B-06970341680497
Reference: 0320205
EMDN: W0201050280
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

CubePlus

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

Manufacturer: opTricon GmbH
Manufacturer SRN: DE-MF-000024656
UDI-DI: 04252020400186
Basic UDI-DI: 42520204CPLUSAP
Reference: CUBE-941-03
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 22:54

Manufacturer products 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

LordsMed Urine Analyser

LM006

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470051
Basic UDI-DI: 890619447LM006F9
Reference: LM006
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed CLIA Reader

LM007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470068
Basic UDI-DI: 890619447LM007FB
Reference: LM007
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

BLOTrix System 4/ BLOTrix Reader S1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270584
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrs1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:30

Manufacturer products View details

BLOTrix System 4/ BLOTrix Reader C1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270553
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrc1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:28

Manufacturer products View details

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205777
Basic UDI-DI: 697457620FGWS01QT
Reference: GFQXY02Q
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details