Public EUDAMED Search

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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Device

3198571

Actor

47657

Certificate

3311

Active filter:EMDN:W0105090103

165 device results listed.

Page 3 / 9

D-W039P0001N5

One Step Strep A Swab Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
D-W039P0001N5
Basic UDI-DI
B-W039P0001N5
Reference
W039P0001
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
France
Authorised representative
QbD RepS BV
Last updated
15.07.2026 13:28
Strep A Antigen Rapid Test

Strep A Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000028093
UDI-DI
D-STA-B02bLE
Basic UDI-DI
B-STA-B02bLE
Reference
STA-B02b
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Netherlands
Authorised representative
SUNGO Europe B.V.
Last updated
15.07.2026 10:45
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN
CN-MF-000009171
UDI-DI
D-IST-502YJ
Basic UDI-DI
B-IST-502YJ
Reference
IST-502
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
14.07.2026 01:42
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN
CN-MF-000009171
UDI-DI
D-IST-501YG
Basic UDI-DI
B-IST-501YG
Reference
IST-501
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
14.07.2026 01:42
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-502aHGL7
Basic UDI-DI
B-GCSTR-502aHGL7
Reference
GCSTR-502a
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-502CaHGUH
Basic UDI-DI
B-GCSTR-502CaHGUH
Reference
GCSTR-502Ca
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCSTR-502CaD3
Basic UDI-DI
B-GCSTR-502CaD3
Reference
GCSTR-502Ca
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCSTR-502CSaJM
Basic UDI-DI
B-GCSTR-502CSaJM
Reference
GCSTR-502CSa
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-502CSaHGAA
Basic UDI-DI
B-GCSTR-502CSaHGAA
Reference
GCSTR-502CSa
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-501aHGKY
Basic UDI-DI
B-GCSTR-501aHGKY
Reference
GCSTR-501a
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-501CaHGU6
Basic UDI-DI
B-GCSTR-501CaHGU6
Reference
GCSTR-501Ca
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:30
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCSTR-501CaCW
Basic UDI-DI
B-GCSTR-501CaCW
Reference
GCSTR-501Ca
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:30
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCSTR-501CSaJE
Basic UDI-DI
B-GCSTR-501CSaJE
Reference
GCSTR-501CSa
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:30
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCSTR-501CSaHG9V
Basic UDI-DI
B-GCSTR-501CSaHG9V
Reference
GCSTR-501CSa
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:30
IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Salofa Oy
Manufacturer SRN
FI-MF-000016823
UDI-DI
D-FIMF168237575STREPAxxGG
Basic UDI-DI
B-FIMF168237575STREPAxxGG
Reference
75-75STREPA-xx
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Sweden
Authorised representative
-
Last updated
13.07.2026 21:32
Strep A Antigen Rapid Test Kit (Colloidal gold method)

Strep A Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN
CN-MF-000054349
UDI-DI
D-CNMF000054349CR023GF
Basic UDI-DI
B-CNMF000054349CR023GF
Reference
CR023
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
13.07.2026 07:07
INDICAID™ Strep A Rapid Antigen Test

INDICAID™ Strep A Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Phase Scientific International Limited
Manufacturer SRN
HK-MF-000025791
UDI-DI
D-A011CL
Basic UDI-DI
B-A011CL
Reference
INDICAID™ Strep A Rapid Antigen Test
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 21:14