Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003982003

FEI Number

3003982003

Entity Name

MEDIVANCE INSTRUMENTS LTD.

City/State/Country

HARLESDEN, LONDON London, City of, GB

Establishment Address

BARRETTS GREEN ROAD, HARLESDEN, LONDON London, City of NW10 7AP, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIVANCE INSTRUMENTS LTD. (Owner Number: 9051184)

Owner / Operator Contact Address

BARRETT'S GREEN ROAD, --, HARLESDEN, LONDON, GB-NOTA NW10 7AP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111167

PMA Number

N/A

All Registered Proprietary Names

Aquacut Quattro AquaCare Twin, AquaCare Single BAG 45S5 Extra/Xtender & Sprint processor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOJ	Airbrush	Dental	Class 2	872.6080	2009-10-19
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-07-17
IXW	Processor, Radiographic-Film, Automatic	Radiology	Class 2	892.1900	2012-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

Registered Agent Solutions, Inc. Registered Agent Solutions, Business: Registered Agent Solutions, Inc. Email: corporateteam2@rasi.com Phone: (888) 2117106

Related Public Records

Same Entity

MEDIVANCE INSTRUMENTS LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003697084	VELOPEX INTERNATIONAL, INC.	Saint Cloud, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940776	Kreativ, Inc.	KREATIV MODEL KV-1	1994-12-21
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003982003. Last updated year: 2026. Please use registration number 3003982003 when referencing this establishment in official correspondence.