Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010092818

FEI Number

3010092818

Entity Name

PROLAB HEALTH & BEAUTY LTD

City/State/Country

Vancouver British Columbia, CA

Establishment Address

1339 Franklin St, Vancouver British Columbia V5L 1P2, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Prolab Health & Beauty Ltd (Owner Number: 10092587)

Owner / Operator Contact Address

1339 Franklin St, Vancouver, CA-BC V5L 1P2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sutil Rich Personal Lubricant Sutil Luxe Personal Lubricant, Vanilla,Coconut and Mint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2025-06-10
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2025-01-23

Official Correspondent

Jonathan Langman

US Agent Details

Leonard Krause Business: FDA Connect, inc. Email: lkrause@fda-connect.com Phone: (541) 2323030

Related Public Records

Same Entity

Prolab Health & Beauty 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 3010092818. Last updated year: 2026. Please use registration number 3010092818 when referencing this establishment in official correspondence.