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Sign in to claim this brandZhejiang Orient Gene Biotech Co., Ltd
China·CN-MF-000017965
Last updated June 8, 2026
Information
- Country
- China
- Address
- 3787#, East Yangguang Avenue, Dipu Street, Anji 313300, Huzhou,Zhejiang, China
- Website
- orientgene.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Joyce Pang
- EUDAMED SRN
- CN-MF-000017965
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (465)
Page 8 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LH Ovulation Rapid Test | GALH-102a-10T | EUDAMED | IVD devices for self-testing | Active |
| COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) | GCCOV(B117)-525a | EUDAMED | IVD General | Active |
| Cell Preservation Solution | N3003B | EUDAMED | Class A | Active |
| General Chemistry I Lyophilized Kit 18 | SYN-001 | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-101d-2T | EUDAMED | IVD devices for self-testing | Active |
| Urine Analyzer | Healgen 501 | EUDAMED | Class A | Active |
| LH Ovulation Rapid Test | GALH-103b-7T | EUDAMED | IVD devices for self-testing | Active |
| Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCBRU-402a | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-102b-5T | EUDAMED | IVD devices for self-testing | Active |
| One Step Multi-Drug Test Dip Card (Urine) | GBDOA-144-007 | EUDAMED | Class B | Active |
| Total IgE Rapid Test Cassette (Serum/Plasma) | GGIGE-302a | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-102b-7T | EUDAMED | IVD devices for self-testing | Active |
| Rotavirus Rapid Test Cassette (Feces) | GCROA-602a | EUDAMED | IVD General | Active |
| One Step Menopause Test Strip (Urine) | GAFSH-101a | EUDAMED | IVD General | Active |
| COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) | GCFC-T502a-H4 | EUDAMED | Class C | Active |
| One Step Multi-Drug Test Dip Card (Urine) | GBDOA-1144-002 | EUDAMED | Class B | Active |
| LH Ovulation Rapid Test | GALH-102a-5T | EUDAMED | IVD devices for self-testing | Active |
| Mini Immunofluorescence Analyzer | OG-H101 | EUDAMED | Class A | Active |
| Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCCHK(IgM)-402a | EUDAMED | IVD General | Active |
| Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma) | GEAFP-401a | EUDAMED | IVD General | Active |
| Chikungunya IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCCHK(IgM/IgG)-402a | EUDAMED | IVD General | Active |
| EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCEV71(IgM)-402a | EUDAMED | IVD General | Active |
| Fecal Occult Blood Rapid Test Strip (Feces) | GEFOB-601b | EUDAMED | IVD General | Active |
| H. pylori Ag Rapid Test Cassette (Feces) | GCHP-602a，GCHP-602Ca | EUDAMED | IVD General | Active |
| Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCMON-402a | EUDAMED | IVD General | Active |
| SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) | GCCOV(NAb)-402b | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-101b-25T | EUDAMED | IVD devices for self-testing | Active |
| HCG Pregnancy Rapid Test | GAHCG-101b-2T | EUDAMED | IVD devices for self-testing | Active |
| Easy @ Home Pregnancy Test | EZW1-MN-2 | EUDAMED | IVD devices for self-testing | Active |
| Influenza A & B Ag Rapid Test Cassette (Swab) | GCFLU(A/B)-502a | EUDAMED | IVD General | Active |
| Monkeypox Virus Detection Kit (Fluorescence PCR) | AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96E | EUDAMED | IVD General | Active |
| Fecal Occult Blood Rapid Test Strip (Feces) | GEFOB-601b | EUDAMED | IVD General | Active |
| One Step Pregnancy Test Strip (Urine) | GAHCG-101b | EUDAMED | IVD General | Active |
| COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) | GCFC-T502a-H2 | EUDAMED | Class C | Active |
| Rapid COVID-19 (Antigen) Self-Test | GCCOV-502a-H3OGE | EUDAMED | IVD devices for self-testing | Active |
| LH Ovulation Rapid Test | GALH-103b-1T | EUDAMED | IVD devices for self-testing | Active |
| Urinalysis Strips | URS-XXT | EUDAMED | IVD General | Active |
| COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) | GCFCRA-T525a | EUDAMED | IVD General | Active |
| Syphilis Ab Rapid Test Strip (Serum/Plasma) | GCSYP-301a | EUDAMED | IVD General | Active |
| Rapid Flu A&B+RSV+Adeno Antigen Test | GCFRA-T525a-DRH7 | EUDAMED | Class C | Active |
| One Step Multi-Drug Test Dip Card (Urine) | GBDOA-1114-002 | EUDAMED | Class B | Active |
| LH Ovulation Rapid Test | GALH-103a-7T | EUDAMED | IVD devices for self-testing | Active |
| One Step Pregnancy Test Cassette (Urine) | GAHCG-102n | EUDAMED | IVD General | Active |
| One Step Microalbumin Test Strip (Urine) | GIHSA-101a | EUDAMED | IVD General | Active |
| COVID-19 Antigen Control Kit | GCCOV(Ag)-PN10，GCCOV(Ag)-PN20 | EUDAMED | IVD General | Active |
| Coronavirus Ag Rapid Test Cassette (Swab) | GCCOV-502a-NN | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-101b-5T | EUDAMED | IVD devices for self-testing | Active |
| One Step Pregnancy Test Strip (Urine) | GAHCG-101n | EUDAMED | IVD General | Active |
| Candida albicans Antigen Rapid Test Cassette (Swab) | GCCA-502a | EUDAMED | IVD General | Active |
| Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma) | GECEA-401a | EUDAMED | IVD General | Active |
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