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EUDAMED Device Search

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TREN

Last updated

17.07.2026 09:39

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Successful

Device

2837068

Actor

47414

Certificate

3106

Active filter:Manufacturer SRN:CN-MF-000005655

370 device results listed.

Page 17 / 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
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI 800

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
06947145513344
Basic UDI-DI
69471455M800QH
Reference
23020003
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 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Waste Bag

Waste Bag

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145513306
Basic UDI-DI
69471455322VY
Reference
21060624
EMDN
W05020105
EMDN description
SAMPLES TRANSPORT, BAGS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Cystatin C (Latex)

Cystatin C (Latex)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145513245
Basic UDI-DI
69471455558WX
Reference
130503006S
EMDN
W01010299
EMDN description
SUBSTRATES - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays LDH Isoenzyme 1 (Chemical inhibition)

LDH Isoenzyme 1 (Chemical inhibition)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512873
Basic UDI-DI
69471455549WW
Reference
130504006A
EMDN
W01010121
EMDN description
LACTATE DEHYDROGENASE ISOENZYMES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays LDH Isoenzyme 1 (Chemical inhibition)

LDH Isoenzyme 1 (Chemical inhibition)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512835
Basic UDI-DI
69471455549WW
Reference
130504006S
EMDN
W01010121
EMDN description
LACTATE DEHYDROGENASE ISOENZYMES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Unsaturated Iron-Binding Capacity (Ferene)

Unsaturated Iron-Binding Capacity (Ferene)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512767
Basic UDI-DI
69471455537WP
Reference
130508002A
EMDN
W01010217
EMDN description
IRON BINDING CAPACITY - TOTAL (CC)
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Reaction Cup

Reaction Cup

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512712
Basic UDI-DI
69471455306W2
Reference
130105000101
EMDN
W0503010203
EMDN description
SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Unsaturated Iron-Binding Capacity (Ferene)

Unsaturated Iron-Binding Capacity (Ferene)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512729
Basic UDI-DI
69471455537WP
Reference
130508002S
EMDN
W01010217
EMDN description
IRON BINDING CAPACITY - TOTAL (CC)
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI System Tubing Cleaning Solution

System Tubing Cleaning Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512705
Basic UDI-DI
69471455305VY
Reference
130299007M
EMDN
W0201020185
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Light Check

Light Check

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512699
Basic UDI-DI
69471455314VZ
Reference
130299006M
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Starter 1+2

Starter 1+2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512682
Basic UDI-DI
69471455302VS
Reference
130299027M
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Starter 1+2

Starter 1+2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512675
Basic UDI-DI
69471455302VS
Reference
130299004M
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Wash Concentrate

Wash Concentrate

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145512644
Basic UDI-DI
69471455303VU
Reference
130299005M
EMDN
W01029003
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Microalbumin (Immunoturbidimetric)

Microalbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145511401
Basic UDI-DI
69471455547WS
Reference
130503004A
EMDN
W0102010309
EMDN description
ALBUMIN (IC) INCL. UALBUMIN
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Microalbumin (Immunoturbidimetric)

Microalbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145511364
Basic UDI-DI
69471455547WS
Reference
130503004S
EMDN
W0102010309
EMDN description
ALBUMIN (IC) INCL. UALBUMIN
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Transferrin (Immunoturbidimetric)

Transferrin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145509774
Basic UDI-DI
69471455529WQ
Reference
130508004A
EMDN
W0102010307
EMDN description
TRANSFERRIN
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI TPA-snibe (CLIA)

TPA-snibe (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145506001
Basic UDI-DI
B-06947145506001
Reference
130201007M
EMDN
W0102030117
EMDN description
TUMOR POLYPEPTIDE ANTIGEN (TPA - INCL. TPS)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Anti-SS-A IgG (CLIA)

Anti-SS-A IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145505905
Basic UDI-DI
B-06947145505905
Reference
130217013M
EMDN
W0102100112
EMDN description
SS-A
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 01:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details