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8-in-1 Respiratory Antigen Combo Rapid Test

RVC-585b-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910659
Basic UDI-DI: 69798909110057D8
Reference: RVC-585b-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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

10-in-1 Respiratory Antigen Combo Rapid Test

RVC-5105a-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910642
Basic UDI-DI: 69798909110058DA
Reference: RVC-5105a-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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 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

Dengue IgG/IgM Rapid Test

DEN-422a-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: 06979890910611
Basic UDI-DI: 69798909110035CW
Reference: DEN-422a-25M
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

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

MONO 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: 06936983104951
Basic UDI-DI: 6970277510000KXX
Reference: IMO-N402-25
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - 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

Dengue NS1 Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104920
Basic UDI-DI: 6970277510001AXE
Reference: IDES-N402-10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM 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: 06936983104890
Basic UDI-DI: 6970277510000ZYV
Reference: IDEN-N402-10
EMDN: W0105099007
EMDN description: DENGUE - 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

Dengue Combo 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: 06936983104876
Basic UDI-DI: 6970277510000LXZ
Reference: IDEC-N425-10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
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

Rotavirus 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: 06936983104746
Basic UDI-DI: 6970277510001CXJ
Reference: IRO-N602-20
EMDN: W0105099099
EMDN description: VIROLOGY - 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

Malaria P.f. /P.v. 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: 06936983104715
Basic UDI-DI: 6970277510000HXR
Reference: IMPV-N402-20
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria P.f. /Pan 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: 06936983104685
Basic UDI-DI: 6970277510000GXP
Reference: IMPN-N402-20
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

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

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