Data / Medical devices / China / Wenzhou Baiyu Glasses Technology Co.,ltd
Wenzhou Baiyu Glasses Technology Co.,ltd: FDA-registered device maker in Wenzhou Zhejiang, China, 2 510(k) clearances
Wenzhou Baiyu Glasses Technology Co.,ltd is registered with the FDA (registration 3038220293) in Wenzhou Zhejiang, China. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038220293
- Address
- No.543 Xiajin Road of South Baixiang St., Ouhai District, Wenzhou Zhejiang, China, 325015
- Owner or operator
- WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD (10094537)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 5, 2025
- Registered through
- 2026
- Brand names listed
- Contact Lens, DRMITSUI ECZEMA RELIEF CREAM, DRMITSUI SODIUM HYALURONATE EYE DROPS, DRMITSUI VAGINAL PROBIOTICS GEL, FluMisch 1cc U-100 Syringes with 5/16"(8mm) 31 Gauge Needle, HKKA BALANCE PATCH, QIDILA 1ml/cc Disposable Syringe with 30G 1/2" (12.7mm) Needle, QIDILA 1ml/cc Disposable Syringe with 31G 1/4" (6mm) Needle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Frame, Spectacle | HQZ | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Exporter to the US | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| July 2, 2024 | K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | ELC | Substantially Equivalent | Shenzhen Micro Electric Intelligence Co., Ltd. | accessdata.fda.gov |
| June 21, 2022 | K213220 | Revaree Plus Vaginal Suppositories | NUC | Substantially Equivalent | Farma-Derma S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Scaler, Ultrasonic
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Lubricant, Personal
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Pad, Menstrual, Unscented
Updated July 2, 2024. 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.