Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613112

FEI Number

3038613112

Entity Name

DONGGUAN YANXUAN BIOTECHNOLOGY CO., LTD

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Room 203, No. 509, Shenyuan 1st Lane, Qiaotou Town, Dongguan City Guangdong 523539, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Yanxuan Biotechnology Co., Ltd (Owner Number: 10093620)

Owner / Operator Contact Address

Room 203, No. 509, Shenyuan 1st Lane, Qiaotou Town, Dongguan City, CN-GD 523539, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243107

PMA Number

N/A

All Registered Proprietary Names

SiYi, Water Solubility Human Body Lubricant, Model: Bestvibe-10ml, Bestvibe-100ml, Bestvibe-120ml, Bestvibe-150ml SiYi, Water Solubility Human Body Lubricant, Model: AquaLuxe Lubricant 500ml, Anosoothe+ Lubricant 150ml SiYi, Water soluble human lubricant, Model:CUPSLAND-10ml, CUPSLAND-100ml, CUPSLAND-120ml, CUPSLAND-150ml, CUPSLAND-200ml SiYi, Water soluble human lubricant, Model: seekheart-200ml, seekheart-240ml, seekheart-300ml SiYi, Water Solubility Human Body Lubricant, Model: ITMT-10ml, ITMT-30ml, ITMT50ml, ITMT-120ml, ITMT-300ml, ITMT-500ml SiYi, Water soluble human lubricant, Model: Goyha-300ml SiYi, Water Solubility Human Body Lubricant, Model: Acmejoy-10ml, Acmejoy-100ml, Acmejoy-120ml, Acmejoy-150ml SiYi, Water soluble human lubricant, Model: VVD-10ml, VVD-100ml, VVD-120ml, VVD-150ml, VVD-200ml, VVD-240ml, VVD-300ml SiYi, Water Solubility Human Body Lubricant, Model: YR-A 120ml, YR-B120ml, YR-C120ml, YR-D 120ml, YR-E 120ml, YR-F 120ml SiYi, Water Solubility Human Body Lubricant, Model: AqueFervor Lubricant 500ml, ArcticHyaluron Lubricant 150ml SiYi, Water soluble human lubricant, Model: seekheart-10ml, seekheart-100ml, seekheart-120ml, seekheart-150ml SiYi, Water Solubility Human Body Lubricant, Model: Bestvibe-200ml, Bestvibe-240ml, Bestvibe-300ml Mrgras, Water Solubility Human Body Lubricant, Model: 8ml, 20ml, 120ml, 200ml, 240ml, 250ml, 300ml, 480ml SiYi, Water soluble human lubricant, Model: Bestvibe-240ml, Bestvibe-300ml SiYi, Water Solubility Human Body Lubricant, Model: Goyha-240ml, Goyha-300ml SiYi, Water soluble human lubricant, Model: Acmejoy-10ml, Acmejoy-100ml, Acmejoy-120ml, Acmejoy-150ml, Acmejoy-200ml SiYi, Water Solubility Human Body Lubricant,Model: VVD-10ml,VVD-100ml,VVD-120ml,VVD-150ml,VVD-200ml, VVD-240ml,VVD-300ml SiYi, Water Solubility Human Body Lubricant, Model: CUPSLAND-200ml, CUPSLAND-240ml, CUPSLAND-300ml SiYi, Water Solubility Human Body Lubricant, Model: 50ml, 100ml, 150ml, 200ml, 220ml, 250ml, 300ml SiYi, Water Solubility Human Body Lubricant, Model: YR-A 300ml,YR-B 300ml,YR-C 300ml,YR-D 300ml,YR-E 300ml,YR-F 300ml SiYi, Water Solubility Human Body Lubricant, Model: AquaLuxe Lubricant 150ml, AquaLuxe Lubricant 300ml SiYi, Water Solubility Human Body Lubricant, Model: seekheart-10ml, seekheart-100ml, seekheart-120ml, seekheart-150ml SiYi, Water Solubility Human Body Lubricant, Model: Goyha-10ml, Goyha-100ml, Goyha-120ml, Goyha-150ml, Goyha-200ml SiYi, Water Solubility Human Body Lubricant, Model: ArcticHyaluron Lubricant 300ml, ArcticHyaluron Lubricant 500ml SiYi, Water soluble human lubricant, Model: Goyha-10ml, Goyha-100ml, Goyha-120ml, Goyha-150ml, Goyha-200ml, Goyha-240ml tracy's dog, Water Solubility Human Body Lubricant, Model: 5ml, 120ml, 240ml, 300ml, 360ml, 400ml, 1000ml SiYi, Water soluble human lubricant, Model:Bestvibe-10ml, Bestvibe-100ml, Bestvibe-120ml, Bestvibe-150ml, Bestvibe-200ml SiYi, Water Solubility Human Body Lubricant, Model: 50ml, 150ml, 500ml,150ml SiYi, Water soluble human lubricant, Model: Acmejoy-240ml, Acmejoy-300ml SiYi, Water soluble human lubricant, Model: CUPSLAND-240ml, CUPSLAND-300ml SiYi, Water Solubility Human Body Lubricant, Model: Acmejoy-200ml, Acmejoy-240ml, Acmejoy-300ml SiYi, Water Solubility Human Body Lubricant, Model: seekheart-200ml, seekheart-240ml, seekheart-300ml SiYi, Water Solubility Human Body Lubricant, Model: CUPSLAND-10ml, CUPSLAND-100ml, CUPSLAND-120ml, CUPSLAND-150ml SiYi, Water Solubility Human Body Lubricant, Model: AqueFervor Lubricant 150ml, AqueFervor Lubricant 300ml SiYi, Water Solubility Human Body Lubricant, Model: Anosoothe+ Lubricant 300ml, Anosoothe+ Lubricant 500ml

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2025-06-13

Official Correspondent

Long Wang

US Agent Details

Tang Thomas Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Dongguan Yanxuan Biotechnology 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
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038613112. Last updated year: 2026. Please use registration number 3038613112 when referencing this establishment in official correspondence.