Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013961642

FEI Number

3013961642

Entity Name

BIO-TECH LUBRICANTS LTD

City/State/Country

Alton Hampshire, GB

Establishment Address

Meadow Barn, Norton Farm, Selborne, Alton Hampshire GU34 3NB, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bio-Tech Lubricants Ltd (Owner Number: 10055817)

Owner / Operator Contact Address

c/o Avonglen Ltd, Epsilon House,, Southampton Science Park, Southampton, GB-HAM SO16 7NS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191411

PMA Number

N/A

All Registered Proprietary Names

AH! YES WB AH! YES OB AH! YES VM AH! YES COCO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2017-10-10
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2022-11-28

Official Correspondent

Tom Clarke

US Agent Details

Michael J Novaria Business: Rubin and Rudman LLP Email: MNovaria@rubinrudman.com Phone: (617) 3307000

Related Public Records

Same Entity

Bio-Tech Lubricants 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 3013961642. Last updated year: 2026. Please use registration number 3013961642 when referencing this establishment in official correspondence.