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SuperFlex

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800015
Basic UDI-DI: 69510458INST_SuperFlexXZ
Reference: SUPERFLEX-CE
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

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Auto Chemiluminescence Immunoassay Analyzer

MT60, MT60S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821472
Basic UDI-DI: 69503348MTA001LH
Reference: MT60S
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:44

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Auto Chemiluminescence Immunoassay Analyzer

MT60, MT60S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821465
Basic UDI-DI: 69503348MTA001LH
Reference: MT60
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:44

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Fully-auto Specific Protein Analyzer

PA480，PA240

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819486
Basic UDI-DI: 69503348PAA005FF
Reference: PA480
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

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06950334819479

PA480，PA240

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819479
Basic UDI-DI: 69503348PAA005FF
Reference: PA240
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

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06950334818434

FA20

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334818434
Basic UDI-DI: 69503348MTA002LK
Reference: FA20
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

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Quantitative lmmunoassay Analyzer

FA30, FA31

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334818168
Basic UDI-DI: 69503348FAA002B7
Reference: FA30
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

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Quantitative lmmunoassay Analyzer

FA50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804444
Basic UDI-DI: 69503348FAA001B5
Reference: FA50
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

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Specific Protein Analyzer

PA50, PA54

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334803300
Basic UDI-DI: 69503348PAA001F7
Reference: PA50
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:39

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Fully-auto Specific Protein Analyzer

PA120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334800965
Basic UDI-DI: 69503348PAA002F9
Reference: PA120
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:37

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Specific Protein Analyzer

PA50, PA54

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334800019
Basic UDI-DI: 69503348PAA001F7
Reference: PA54
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:36

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06948500937560

Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Guangzhou LBP Medicine Science & Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000026786
UDI-DI: 06948500937560
Basic UDI-DI: 69485009IHC001KL
Reference: 198-242V：CCP.000145-2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 28.06.2026 04:11

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06948500936730

Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou LBP Medicine Science & Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000026786
UDI-DI: 06948500936730
Basic UDI-DI: 69485009IHC001KL
Reference: CCP.000133
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 28.06.2026 04:10

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HiLIA 1251i

IVD Class ANot specifiedOn the market

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980315375
Basic UDI-DI: 69269803YQHiLIA1250i3F
Reference: CK-KR-BLOT-006
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 28.06.2026 02:11

Manufacturer products Authorised representative products Authorised representative actors View details

HiLIA 1252i

IVD Class ANot specifiedOn the market

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980315382
Basic UDI-DI: 69269803YQHiLIA1250i3F
Reference: CK-KR-BLOT-007
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 28.06.2026 02:11

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06926980316907

IVD Class ANot specifiedOn the market

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316907
Basic UDI-DI: 69269803YQKaeser2000UX
Reference: CK-KR-CLIA-002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 28.06.2026 02:11

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MAGLUMI X6

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145528782
Basic UDI-DI: 69471455X6GB
Reference: 010101006601
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

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Preaccu

Preaccu for Prenatal Screening

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145513597
Basic UDI-DI: 69471455Preaccu6W
Reference: 22010315
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

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MAGLUMI X3

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145513481
Basic UDI-DI: 69471455X3G5
Reference: 010101003301
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

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MAGLUMI X8

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145513467
Basic UDI-DI: 69471455X8GF
Reference: 010101008801
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

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