Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004512585

FEI Number

3004512585

Entity Name

FLEXIBLE MEDICAL PACKAGING LTD.

City/State/Country

LANCASTER Lancashire, GB

Establishment Address

UNIT 8, HIGHTOWN, WHITECROSS INDUSTRIAL ESTATE, LANCASTER Lancashire LA1 4XS, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flexible Medical Packaging Ltd (Owner Number: 9035506)

Owner / Operator Contact Address

Unit 8 Hightown, White Cross Industrial Estate, Lancaster, GB-LAN LA1 4XS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Opticell Optifoam Opticell Ag Liberty Soft Skin Adhesive remover WELLAND ADHESIVE REMOVER WELLAND BARRIER FILM Liberty Soft Skin Barrier Flim Opticell Opticell Ag Optifoam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2022-07-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2011-06-06
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2006-12-22
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2025-04-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-06-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-07-18
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2016-06-30

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Flexible Medical Packaging 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
3013510154	FLEXIBLE MEDICAL PACKAGING LTD.	MORECAMBE Lancashire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004512585. Last updated year: 2026. Please use registration number 3004512585 when referencing this establishment in official correspondence.