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Adenovirus Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104630
Basic UDI-DI: 6970277510000YYT
Reference: IAD-N602-20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104463
Basic UDI-DI: 6970277510000FXM
Reference: ISY-N401
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104449
Basic UDI-DI: 6970277510000EXK
Reference: IHP-N402
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062778066
Basic UDI-DI: 69520627J012L3
Reference: SL030101NST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE14-COVAg-6.6 · Rev. A/4
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774020
Basic UDI-DI: 69520627J034LD
Reference: CFRA1ST-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE80-CFRA-6-6 · Rev. A7
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

H.Pylori Antigen Test Kit

Cassette Tube Strip

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062711643
Basic UDI-DI: 69520627J016LB
Reference: HPAg1FEST-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-HPAG-6.6 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062710714
Basic UDI-DI: 69520627J017LD
Reference: COVAg+FluAB1NST-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): SL-CE81-COVAg+FluAB-6.6 · Rev. A5
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080096
Basic UDI-DI: 5944759080VTSTA25STSMB6Y7
Reference: VT-STA-25
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080058
Basic UDI-DI: 5944759080VTSYP25WBSPC3BE
Reference: VT-SYP-25
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080010
Basic UDI-DI: 5944759080VTHPB25SPROB6HC
Reference: VT-HPBSP-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

Capilia TB-Neo 100T/Box

Capilia TB-Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815008703
Basic UDI-DI: 4987815TB019Z
Reference: CATB0870
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Portugal
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Strep A Test

Strep A Test

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: 04065384000172
Basic UDI-DI: 4065384STA1OPS4N1GXEW
Reference: 20122N20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

LYHER

303045201-01;303045201-05;303045201-20;303045201-25;303045201-40

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612031
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303041901

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611478
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-25
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test

Trichomonas vaginalis/Gardnerella vaginalis/ Candida albicans Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITGC-535J7
Basic UDI-DI: B-ITGC-535J7
Reference: ITGC-535
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-502SC
Basic UDI-DI: B-ISB-502SC
Reference: ISB-502
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-501SA
Basic UDI-DI: B-ISB-501SA
Reference: ISB-501
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0270

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 20608337000560
Basic UDI-DI: B-20608337000560
Reference: 1001-0270
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O1/O139 Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IVCAB-ACO627BC
Basic UDI-DI: B-IVCAB-ACO627BC
Reference: IVCAB-ACO627
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ITYM-ACO402S9
Basic UDI-DI: B-ITYM-ACO402S9
Reference: ITYM-ACO402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details