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D-69509960AFAB01L6PY

AFAB01-AOG48E; AFAB01-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AFAB01L6PY
Basic UDI-DI: B-69509960AFAB01L6PY
Reference: AFAB01-AOG48E; AFAB01-AOG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AFAB03LAQW

AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AFAB03LAQW
Basic UDI-DI: B-69509960AFAB03LAQW
Reference: AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960ACAB04DJXYT

ACAB04D-BOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ACAB04DJXYT
Basic UDI-DI: B-69509960ACAB04DJXYT
Reference: ACAB04D-BOG48E
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69384449ROTA3Y

strip, cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Equinox Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018901
UDI-DI: D-69384449ROTA3Y
Basic UDI-DI: B-69384449ROTA3Y
Reference: RH-ROTA
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:51

Manufacturer products Authorised representative products Authorised representative actors View details

6970277510023AXW

Malaria P.f./P.v. Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 6970277510023AXW
Basic UDI-DI: B-6970277510023AXW
Reference: IMPV-401
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit

Flu Cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757993821RC
Basic UDI-DI: B-693757993821RC
Reference: Flu Cassette
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)

MA-Pan/Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991703QP
Basic UDI-DI: B-693757991703QP
Reference: MA-Pan/Pf 50170301 MA-Pan/Pf 25170302
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)

MA-Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991702QM
Basic UDI-DI: B-693757991702QM
Reference: MA-Pf 50170101 MA-Pf 25170102
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)

MA-Pf/Pv strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991701QK
Basic UDI-DI: B-693757991701QK
Reference: MA-Pf/Pv 50170201 MA-Pf/Pv 25170202
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Actim® Influenza A&B

32837ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990424TT
Basic UDI-DI: B-6430030990424TT
Reference: 32837ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Influenza A&B

32836ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990417TW
Basic UDI-DI: B-6430030990417TW
Reference: 32836ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Influenza A&B

32834ETAC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990264TV
Basic UDI-DI: B-6430030990264TV
Reference: 32834ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Influenza A&B

32832ETAC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990240TF
Basic UDI-DI: B-6430030990240TF
Reference: 32832ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723972
Basic UDI-DI: B-62230182723972
Reference: D-788 001
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Rapid Test Cassette (Fecal Specimen)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723804
Basic UDI-DI: B-62230182723804
Reference: D-794 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723590
Basic UDI-DI: B-62230182723590
Reference: D-796 001
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723736
Basic UDI-DI: B-62230182723736
Reference: D-793 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

1192 001

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041043500
Basic UDI-DI: B-62230041043500
Reference: 1192 001
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Test

1184 001

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041023496
Basic UDI-DI: B-62230041023496
Reference: 1184 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Test

1180 001

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041023328
Basic UDI-DI: B-62230041023328
Reference: 1180 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details