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D-69509960RMTB01ZMGA

RMTB01-AHG5E, RMTB01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960RMTB01ZMGA
Basic UDI-DI: B-69509960RMTB01ZMGA
Reference: RMTB01-AHG5E, RMTB01-AHG25E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960ANG01QDQJ

ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ANG01QDQJ
Basic UDI-DI: B-69509960ANG01QDQJ
Reference: ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMTBC01WULG

AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMTBC01WULG
Basic UDI-DI: B-69509960AMTBC01WULG
Reference: AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
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-69509960AMP01RKTR

AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMP01RKTR
Basic UDI-DI: B-69509960AMP01RKTR
Reference: AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
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-69509960AGAS01P6WQ

AGAS01-AOG48E; AGAS01D-AOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AGAS01P6WQ
Basic UDI-DI: B-69509960AGAS01P6WQ
Reference: AGAS01-AOG48E; AGAS01D-AOG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
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-69509960ABPTS02XHQ3

ABPTS02-AOG48E/ ABPTS02-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ABPTS02XHQ3
Basic UDI-DI: B-69509960ABPTS02XHQ3
Reference: ABPTS02-AOG48E/ ABPTS02-AOG96E
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
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

Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)

HP-Ag strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991602QG
Basic UDI-DI: B-693757991602QG
Reference: HP-Ag501601 HP-Ag251602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

H.Pylori Antibody (HP) Test

HP strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991601QE
Basic UDI-DI: B-693757991601QE
Reference: HP strip cassette
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
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

Typhoid IgG/IgM test cassette

Typhoid-IgG/IgM cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990620QB
Basic UDI-DI: B-693757990620QB
Reference: Typhoid-IgG/IgM 252002
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
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 Antibody to Treponema Pallidum (Colloidal Gold)

TP strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990609QP
Basic UDI-DI: B-693757990609QP
Reference: TP500901 TP250902
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
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

Typhoid IgG/IgM Rapid Test- Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723668
Basic UDI-DI: B-62230182723668
Reference: D-792 001
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
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

Widal Test (Salmonella Ab)