Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009701308

FEI Number

3009701308

Entity Name

POLARSEAL TAPES AND CONVERSIONS

City/State/Country

Saxmundham Suffolk, GB

Establishment Address

34-36 Carlton Park Industrial Estate, Carlton, Saxmundham Suffolk IP17 2NL, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PolarSeal Tapes and Conversions Ltd (Owner Number: 10041829)

Owner / Operator Contact Address

PolarSeal Tapes and Conversions, Guildford Trading Estate, Farnham, GB-SRY GU9 9PZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CathAttach

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-09-07
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2019-03-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-06-06
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2022-09-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-06-03

Official Correspondent

Carrie Borton

US Agent Details

Daryl Wisdahl Business: MedEnvoy Global Inc. Email: usagent@medenvoyglobal.com Phone: (512) 2560570

Related Public Records

Same Entity

PolarSeal Tapes and Conversions 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
3013526501	POLARSEAL TAPES AND CONVERSIONS LTD	Farnham Surrey, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009701308. Last updated year: 2026. Please use registration number 3009701308 when referencing this establishment in official correspondence.