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RSS III

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

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: 04065384000158
Basic UDI-DI: 4065384RSS36N1Y3
Reference: 61100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

VIDAS® 3 ASSAY DILUTION CUP

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026612849
Basic UDI-DI: 357302BUDI000296TT
Reference: 542653
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

Manufacturer products View details

IMMAGE 800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265403
Basic UDI-DI: 150995901A15445PU
Reference: A15445
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 Immunoassay System

81600N

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265380
Basic UDI-DI: 150995901Acc2FR
Reference: 81600N
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265373
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301660
Basic UDI-DI: 06936895BS016K4
Reference: BK-PA120
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

HumaReader HS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145185727
Basic UDI-DI: 04033145EL16670K4
Reference: 16670
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Croatia
Authorised representative: -
Last updated: 30.07.2026 18:27

Manufacturer products View details

Elisys Uno

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145086901
Basic UDI-DI: 04033145EL17350JN
Reference: 17350
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

Elisys Duo

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145086895
Basic UDI-DI: 04033145EL17200J2
Reference: 17200
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

Elisys Quattro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145079613
Basic UDI-DI: 04033145EL16300HY
Reference: 16300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

CombiWash

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145036418
Basic UDI-DI: 04033145EL18460K5
Reference: 18460
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90

AST-Dx90

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Astrabio Technology Co., Ltd.
Manufacturer SRN: CN-MF-000041763
UDI-DI: 06977100860244
Basic UDI-DI: 697710086ASTMYN9
Reference: 8901000100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

04049095260810

RIDA® Vision

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260810
Basic UDI-DI: 4049095ZG85920000WU
Reference: ZG8592
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 08:01

Manufacturer products View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820028
Basic UDI-DI: 69332898CE2001EG
Reference: WP13
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820042
Basic UDI-DI: 69332898CE2001EG
Reference: WP16
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

FC-2000 (WP13, WP16, WP18), FC-2100 (WP14, WP17, WP19)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820059
Basic UDI-DI: 69332898CE2001EG
Reference: WP17
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820066
Basic UDI-DI: 69332898CE2001EG
Reference: WP18
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820035
Basic UDI-DI: 69332898CE2001EG
Reference: WP14
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820073
Basic UDI-DI: 69332898CE2001EG
Reference: WP19
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Transfer Module Aliquot Segment

IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Mod Aliquot Segment

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014048
Basic UDI-DI: 0405686901020UG
Reference: 10445571
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details