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EUDAMED Device Search

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

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22.09.2026 04:18

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Rapid Anti-TB (Mycobacterium Tuberculosis) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803675
Basic UDI-DI: B-06936155803675
Reference: ITP09002-TC40
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:12

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141314
Basic UDI-DI: B-06936020141314
Reference: IVD109-02-20t
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141307
Basic UDI-DI: B-06936020141307
Reference: IVD109-02-10t
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141291
Basic UDI-DI: B-06936020141291
Reference: IVD109-02-05t
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141284
Basic UDI-DI: B-06936020141284
Reference: IVD109-02-01t
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141154
Basic UDI-DI: B-06936020141154
Reference: IVD105-02-20t
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141147
Basic UDI-DI: B-06936020141147
Reference: IVD105-02-10t
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141130
Basic UDI-DI: B-06936020141130
Reference: IVD105-02-05t
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141123
Basic UDI-DI: B-06936020141123
Reference: IVD105-02-01t
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140713
Basic UDI-DI: B-06936020140713
Reference: HP-02-20t
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140706
Basic UDI-DI: B-06936020140706
Reference: HP-02-10t
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140690
Basic UDI-DI: B-06936020140690
Reference: HP-02-5t
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140683
Basic UDI-DI: B-06936020140683
Reference: HP-02-1t
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Rapid Test (Immunochromatography)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091672017
Basic UDI-DI: B-06935091672017
Reference: /
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Croatia
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091671812
Basic UDI-DI: B-06935091671812
Reference: /
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ferrarihub

IVD generalNot specifiedOn the marketSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: 06934078018749
Basic UDI-DI: B-06934078018749
Reference: ISTA-RC81
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

QuikRead go Strep A

IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001034
Basic UDI-DI: B-06438115001034
Reference: 135883
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:07

Manufacturer products View details

Artron Treponema Pallidum (TP) Antibody Test

IVD Class CIVDR 2017/746On the marketKitNear-patient testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561130
Basic UDI-DI: 62834756AL02090279
Reference: A02-09-322P
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-TP Ab(WB)-2024 · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Capilia TB-Neo 10T/Box

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815008710
Basic UDI-DI: 4987815TB019Z
Reference: CATB0871
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Portugal
Authorised representative: Emergo Europe B.V.
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

05902643958968

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958968
Basic UDI-DI: 59026439CRTL916RB
Reference: 1-916-2502
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:12

Manufacturer products View details