Data / Medical devices / China / Guangzhou Hehong Biotech Co., Ltd.
Guangzhou Hehong Biotech Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances
Guangzhou Hehong Biotech Co., Ltd. is registered with the FDA (registration 3043639843) in Guangzhou Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3043639843
- Address
- A zone, 2/F, Building A, Huazi Industrial Park, Shilou Town, Panyu District, Guangzhou Guangdong, China, 511447
- Owner or operator
- Guangzhou Hehong Biotech Co., Ltd. (10093562)
- Roles
- Manufacturer
- First device listed
- January 12, 2026
- Registered through
- 2027
- Brand names listed
- Minvitro, Minvitro Vitrification Straw
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | 2 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2026 | K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | MQF | Substantially Equivalent | Guangzhou Hehong Biotech Co., Ltd. | accessdata.fda.gov |
| February 3, 2025 | K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | MQK | Substantially Equivalent | Guangzhou Hehong Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.