Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044178

FEI Number

3003080333

Entity Name

Advanced Medical Solutions Ltd

City/State/Country

WINSFORD Cheshire East, GB

Establishment Address

Premier Park, 33 Road One, WINSFORD INDUSTRIAL ESTATE, WINSFORD Cheshire East CW7 3RT, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADVANCED MEDICAL SOLUTIONS GROUP PLC (Owner Number: 9031453)

Owner / Operator Contact Address

PREMIER PARK, 33 ROAD ONE,, WINSFORD INDUSTRIAL ESTATE,, WINSFORD, GB-CHE CW7 3RT, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183645

PMA Number

N/A

All Registered Proprietary Names

Tegaderm Alginate Ag Cardinal Health Reinforced Gelling Fiber +Ag Restore Calcium Alginate Dressing, Silver McKesson Calcium Alginate Dressings Antimicrobial Silver RESTORE SILVER REINFORCED Calcicare Calcium Alginate Silver Dressing Biatain® Alginate Ag Melgisorb® Ag Cardinal Health Essentials Reinforced Silver Calcium Alginate Dressing Surgical Silver Postoperative Dressings Hydrocolloid ActivHeal® Surgical Ag Primaseal Post Op AG+ ActivHeal® Non Adhesive PHMB Foam McKesson PHMB Hydrophilic Foam Dressing Non Adhesive, Anti-Bacterial Normlgel® Ag Cardinal Health Essentials Silver Amorphous Hydrogel McKesson Silver Antimicrobial Wound Gel Cardinal Health Hydrogel +Ag Tegaderm Alginate McKesson Gelling Fiber Dressings Maxorb® Extra ES CalciCare Calcium Alginate Dressing CALCICARE REINFORCED Alginate Restore Calcium Alginate Dressing ActivHeal® Alginate Maxorb® Extra Biatain® Alginate Cardinal Health Reinforced Gelling Fiber ActivHeal® AquaFiber Extra McKesson Calcium Alginate Dressing ActivHeal® AquaFiber Cardinal Health Essential Reinforced Calcium Alginate Dressing ActivHeal® Actibride Maxorb® Extra AG+ Maxorb® ES AG+ 3M SILVERCEL® Hydro-Alginate Antimicrobial Dressing with Silver ACTIVHEAL® SILVER FIBER Ag ActivHeal® AquaFiber Ag Simpurity Fibergel Ag ActivHeal® Raponicel Ultra ActivHeal® Hydrogel 3M SILVERCEL® Nonadherent Hydro-Alginate Antimicrobial Dressing McKesson Gelling Fiber Ag Dressings ACTIVHEAL® Aquafiber Extra Ag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-03-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-08-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-08-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-04-01
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-12-03
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-12-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-10-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-10-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-11-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-03-01
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2007-12-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-10-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-05

Official Correspondent

ROSE GUANG

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

ADVANCED MEDICAL SOLUTIONS GROUP PLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005433617	Medizin Produkte Neustadt GmbH (MPN)	Saal/Donau Bavaria, DE
3002673655	BIOMATLANTE	VIGNEUX DE BRETAGNE Loire-Atlantique, FR
3015330532	Medizin Produkte Neustadt GmbH (MPN)	Neustadt in Holstein Schleswig-Holstein, DE
9617175	Advanced Medical Solutions Limited	PLYMOUTH Devon, GB
3014592276	Resorba, s.r.o	Domazlice, CZ

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

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3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044178. Last updated year: 2026. Please use registration number 8044178 when referencing this establishment in official correspondence.