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H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma)

GCHP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-401aYS
Basic UDI-DI: B-GCHP-401aYS
Reference: GCHP-401a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Cassette (Serum/Plasma)

GCHP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-302aYN
Basic UDI-DI: B-GCHP-302aYN
Reference: GCHP-302a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Strip (Serum/Plasma)

GCHP-301a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-301aYK
Basic UDI-DI: B-GCHP-301aYK
Reference: GCHP-301a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Rapid Test Cassette (Swab)

GCGON-502b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCGON-502bHG3H
Basic UDI-DI: B-GCGON-502bHG3H
Reference: GCGON-502b
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Rapid Test Cassette (Swab)

GCGON-502b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCGON-502b3G
Basic UDI-DI: B-GCGON-502b3G
Reference: GCGON-502b
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCRE-T1402a25
Basic UDI-DI: B-GCCRE-T1402a25
Reference: GCCRE-T1402a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia Trachomatis Antigen Rapid Test (Cassette) (Swab/Urine)

GCCHL-502a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHL-502aUE
Basic UDI-DI: B-GCCHL-502aUE
Reference: GCCHL-502a
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces)

GCCD-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD-602aRS
Basic UDI-DI: B-GCCD-602aRS
Reference: GCCD-602a
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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Clostridium difficile Toxin A&B Rapid Test Casette (Feces)

GCCD(Toxin A/B)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(ToxinAB)-602aZC
Basic UDI-DI: B-GCCD(ToxinAB)-602aZC
Reference: GCCD(Toxin A/B)-602a
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCBRU-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCBRU-402aHG4Q
Basic UDI-DI: B-GCBRU-402aHG4Q
Reference: GCBRU-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)

GCCD(GDH)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(GDH)-602aH3
Basic UDI-DI: B-GCCD(GDH)-602aH3
Reference: GCCD(GDH)-602a
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCBRU-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCBRU-402a4N
Basic UDI-DI: B-GCBRU-402a4N
Reference: GCBRU-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCBRU(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCBRU(IgG/IgM)-402aHGMN
Basic UDI-DI: B-GCBRU(IgG/IgM)-402aHGMN
Reference: GCBRU(IgG/IgM)-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCBRU(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCBRU(IgG/IgM)-402a3Y
Basic UDI-DI: B-GCBRU(IgG/IgM)-402a3Y
Reference: GCBRU(IgG/IgM)-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

RapiSyph Rapid Antibody Test kit for Syphilis

G2MR172515

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MR172515JP
Basic UDI-DI: B-G2MR172515JP
Reference: G2MR172515, G2MR170115
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Med4Me Tuberculosis Panel

G2MMAP10001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MMAP10001LS
Basic UDI-DI: B-G2MMAP10001LS
Reference: G2MMAP10001-ill; G2MMAP10001-TF; G2MMAP10001-MG
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

TB-Q Comprehensive Real Time PCR Kit for Tuberculosis

G2M803121

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803121F2
Basic UDI-DI: B-G2M803121F2
Reference: G2M803121,G2M803121R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

N. Gonorrhoeae-Q Real-Time PCR Kit

G2M706421

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706421FR
Basic UDI-DI: B-G2M706421FR
Reference: G2M706421, G2M706421R
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

MTC-Q Real-Time PCR Kit

G2M707321

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707321FT
Basic UDI-DI: B-G2M707321FT
Reference: G2M707321,G2M707321R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori-Q Real-Time PCR Kit

G2M706321,G2M706321R

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706321FL
Basic UDI-DI: B-G2M706321FL
Reference: G2M706321
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details