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EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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Active filter:EMDN:W01021521

305 device results listed.

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D-IM4293501L9

Chemiluminescence Immunoassay Multi-analytes (CIM) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4293501L9
Basic UDI-DI
B-IM4293501L9
Reference
IM4293501
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4292507LE

Down Syndrome Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4292507LE
Basic UDI-DI
B-IM4292507LE
Reference
IM4292507
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4292502L4

Chemiluminescence Immunoassay Multi-analytes (CIM) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4292502L4
Basic UDI-DI
B-IM4292502L4
Reference
IM4292502
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4292501L2

Chemiluminescence Immunoassay Multi-analytes (CIM) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4292501L2
Basic UDI-DI
B-IM4292501L2
Reference
IM4292501
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4291507L7

Down Syndrome Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4291507L7
Basic UDI-DI
B-IM4291507L7
Reference
IM4291507
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4291502KV

Chemiluminescence Immunoassay Multi-analytes (CIM) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4291502KV
Basic UDI-DI
B-IM4291502KV
Reference
IM4291502
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
D-IM4291501KT

Chemiluminescence Immunoassay Multi-analytes (CIM) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4291501KT
Basic UDI-DI
B-IM4291501KT
Reference
IM4291501
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
14.07.2026 01:13
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDPC-LP3HH
Basic UDI-DI
B-FDPC-LP3HH
Reference
FDPC-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:22
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDPC-LP3HG6B
Basic UDI-DI
B-FDPC-LP3HG6B
Reference
FDPC-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:22
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDINF-LP3HG9J
Basic UDI-DI
B-FDINF-LP3HG9J
Reference
FDINF-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:22
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDINF-LP3BQ
Basic UDI-DI
B-FDINF-LP3BQ
Reference
FDINF-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:20
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDDCB-PN20VM
Basic UDI-DI
B-FDDCB-PN20VM
Reference
FDDCB-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:20
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDDCB-PN20HGWE
Basic UDI-DI
B-FDDCB-PN20HGWE
Reference
FDDCB-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:20
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDCS-PN20HG35
Basic UDI-DI
B-FDCS-PN20HG35
Reference
FDCS-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDCS-PN2076
Basic UDI-DI
B-FDCS-PN2076
Reference
FDCS-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDCAR-PN20HG5N
Basic UDI-DI
B-FDCAR-PN20HG5N
Reference
FDCAR-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDCAR-PN202K
Basic UDI-DI
B-FDCAR-PN202K
Reference
FDCAR-PN20
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FDCAR-LP3HG3V
Basic UDI-DI
B-FDCAR-LP3HG3V
Reference
FDCAR-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FDCAR-LP37D
Basic UDI-DI
B-FDCAR-LP37D
Reference
FDCAR-LP3
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.07.2026 21:19
D-EIM4298507KQ

Maternal Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-EIM4298507KQ
Basic UDI-DI
B-EIM4298507KQ
Reference
EIM4298507
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
13.07.2026 18:57