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818 device results listed.

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H. pylori Antigen Rapid Test

HP-602a-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910635
Basic UDI-DI: 69798909110038D4
Reference: HP-602a-25M
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

HP-402b-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910628
Basic UDI-DI: 69798909110037D2
Reference: HP-402b-25M
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983185721
Basic UDI-DI: 6970277510015CY3
Reference: ICH-N502H-01
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007702-SSP · Rev. 2
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

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

S. pneumoniae Antigen Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104975
Basic UDI-DI: 6970277510001DXL
Reference: ISP-N102-10
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella typhi Antigen Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104838
Basic UDI-DI: 6970277510001EXN
Reference: ISTY-N602-20
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104807
Basic UDI-DI: 6970277510001BXG
Reference: ILEG-N102-25
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen 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: 06936983104654
Basic UDI-DI: 6970277510000JXV
Reference: IHP-N601-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
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

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

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

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

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

Typhoid IgG Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ITYG-ACO402NP
Basic UDI-DI: B-ITYG-ACO402NP
Reference: ITYG-ACO402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details