Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038220293

FEI Number

3038220293

Entity Name

WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.543 Xiajin Road of South Baixiang St., Ouhai District, Wenzhou Zhejiang 325015, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD (Owner Number: 10094537)

Owner / Operator Contact Address

No.543 Xiajin Road of South Baixiang St., Ouhai District, Wenzhou, CN-ZJ 325015, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213220

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-05-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-05-11
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-05
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2026-04-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-05-06
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2026-04-12
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-05-08
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2026-05-08

Official Correspondent

Damon Lin

US Agent Details

JACLINE BOBOIGE Email: boboigechen@gmail.com Phone: (414) 9442888

Related Public Records

Same Entity

WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038220293. Last updated year: 2026. Please use registration number 3038220293 when referencing this establishment in official correspondence.