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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

23.09.2026 08:13

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Successful

Device

3541253

Actor

47797

Certificate

3399

Active filter:Manufacturer SRN:CN-MF-000005655

377 device results listed.

Page 6 / 19

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Biossays Pancreatic Amylase (Immunoinhibition-EPS)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558192
Basic UDI-DI
69471455639WY
Reference
130506003A
EMDN
W01010108
EMDN description
AMYLASE ISOENZYMES
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
10.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Pancreatic Amylase Calibrator

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558222
Basic UDI-DI
69471455639WY
Reference
160202639C
EMDN
W01010108
EMDN description
AMYLASE ISOENZYMES
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
10.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Biossays Pancreatic Amylase Controls

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558239
Basic UDI-DI
69471455639WY
Reference
160202639Q
EMDN
W01010108
EMDN description
AMYLASE ISOENZYMES
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
10.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi D-Dimer Controls

D-Dimer Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558727
Basic UDI-DI
B-06947145558727
Reference
1602047153QLSN
EMDN
W0103020799
EMDN description
HAEMOSTASIS CONTROLS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi FDP Controls

FDP Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558628
Basic UDI-DI
B-06947145558628
Reference
1602047152QLSN
EMDN
W0103020799
EMDN description
HAEMOSTASIS CONTROLS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Coagulation Controls

Coagulation Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558550
Basic UDI-DI
B-06947145558550
Reference
1601040003SN
EMDN
W0103020799
EMDN description
HAEMOSTASIS CONTROLS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Coagulation Controls

Coagulation Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558543
Basic UDI-DI
B-06947145558543
Reference
1601040004SN
EMDN
W0103020799
EMDN description
HAEMOSTASIS CONTROLS - OTHER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi D-Dimer Calibrators

D-Dimer Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558390
Basic UDI-DI
B-06947145558390
Reference
1602047103CTSN
EMDN
W0103020701
EMDN description
CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi FDP Calibrators

FDP Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558345
Basic UDI-DI
B-06947145558345
Reference
1602047102CTSN
EMDN
W0103020701
EMDN description
CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Coagulation Calibrators

Coagulation Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145558284
Basic UDI-DI
B-06947145558284
Reference
1601040001SN
EMDN
W0103020701
EMDN description
CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi D-Dimer (Latex)

D-Dimer (Latex)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145555023
Basic UDI-DI
B-06947145555023
Reference
133101007NSNS1
EMDN
W0103020503
EMDN description
D-DIMER
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi FDP (Latex)

FDP (Latex)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145554804
Basic UDI-DI
B-06947145554804
Reference
133101006NSNS1
EMDN
W0103020502
EMDN description
FIBRINOGEN DEGRADATION PRODUCTS
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi AT III (Chromogenic Substrate Assay)

AT III (Chromogenic Substrate Assay)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145554590
Basic UDI-DI
B-06947145554590
Reference
133101005NSNS1
EMDN
W0103020602
EMDN description
ANTITHROMBIN
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Fibrinogen (Clotting Assay)

Fibrinogen (Clotting Assay)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145554316
Basic UDI-DI
B-06947145554316
Reference
133101004NSNM1
EMDN
W0103020201
EMDN description
FIBRINOGEN ASSAYS (FACTOR I)
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi TT (Clotting Assay)

TT (Clotting Assay)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145554071
Basic UDI-DI
B-06947145554071
Reference
133101003NSNM1
EMDN
W0103020103
EMDN description
THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi APTT (Clotting Assay)

APTT (Clotting Assay)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145553838
Basic UDI-DI
B-06947145553838
Reference
133101002NSNM1
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
06.07.2026 11:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Reaction Module

Reaction Module

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
16947145512658
Basic UDI-DI
69471455301VQ
Reference
630003
EMDN
W0503010203
EMDN description
SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 10:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Coagulation analyzer cleaning solution 1

Coagulation analyzer cleaning solution 1

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145588328
Basic UDI-DI
694714553514JW
Reference
133199003N
EMDN
W0202020185
EMDN description
COAGULOMETERS - CONSUMABLES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 10:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hemolumi Coagulation analyzer cleaning solution 2

Coagulation analyzer cleaning solution 2

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145588311
Basic UDI-DI
694714557210K3
Reference
130104004N
EMDN
W0202020185
EMDN description
COAGULOMETERS - CONSUMABLES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 10:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Progesterone (CLIA) Controls

Progesterone (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145586294
Basic UDI-DI
694714551049JA
Reference
1602011049MT
EMDN
W0102152002
EMDN description
HORMONE CONTROLS
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 10:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details