FDA Registration
Active
🇨🇳 China
WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD
Reg #: 3038220293
·
FEI: 3038220293
·
Expires 2026
Products
11
Proprietary Names
24
Establishment Types
3
Classifications
11
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Registration Details
- Registration Name
- WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD
- Registration Number
- 3038220293
- FEI Number
- 3038220293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.543 Xiajin Road of South Baixiang St., Ouhai District
- City
- Wenzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240707
Owner / Operator
- Firm Name
- WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD
- Operator Number
- 10094537
- Address
- No.543 Xiajin Road of South Baixiang St., Ouhai District
- City
- Wenzhou
- State
- Zhejiang
- Postal Code
- 325015
- Country
- CN
- Correspondent
- Damon Lin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2026-05-08 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2026-05-11 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2025-12-05 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2026-04-12 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-05-06 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2026-04-12 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2026-05-08 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2026-05-08 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2025-12-05 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-01-17 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2026-01-17 |
Proprietary Names
DRMITSUI ECZEMA RELIEF CREAM
HKKA BALANCE PATCH
safety glasses
reading glasses
sunglasses
magnifying glass
optical glasses
Tooth cleaner G68
skin tag remover kit
Women period underwear 2211 8003
DRMITSUI SODIUM HYALURONATE EYE DROPS
DRMITSUI VAGINAL PROBIOTICS GEL
telescope
Contact Lens
FluMisch 1cc U-100 Syringes with 5/16"(8mm) 30 Gauge Needle
Harsso 1ml/cc Disposable Syringe with 31G 5/16" (8mm) Needle
Arthcal U-100 Syringes, 1ml/cc, with 30G 5/16" (8mm) Needles
Arthcal U-100 Syringes, 1ml/cc, with 31G 1/4" (6mm) Needles
Arthcal U-100 Syringes, 1ml/cc, with 29G 1/2" (12.7mm) Needles
Arthcal U-100 Syringes, 0.5ml/cc, with 30G 5/16" (8mm) Needles
Harsso 1ml/cc Disposable Syringe with 30G 5/16" (8mm) Needle
FluMisch 1cc U-100 Syringes with 5/16"(8mm) 31 Gauge Needle
FluMisch 0.5cc U-100 Syringes with 5/16"(8mm) 31 Gauge Needle
Arthcal U-100 Syringes, 1ml/cc, with 31G 5/16" (8mm) Needles
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)