ARDEN MEDICAL LTD.

FDA Device Registration & Listing · ALCESTER, WARKS Warwickshire, GB · Registration 3003516784

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003516784
FEI Number
3003516784
Entity Name
ARDEN MEDICAL LTD.
City/State/Country
ALCESTER, WARKS Warwickshire, GB
Establishment Address
ARDEN ROAD, ARDEN FOREST IND. EST., ALCESTER, WARKS Warwickshire B49 6HN, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ARDEN MEDICAL LTD. (Owner Number: 9048692)
Owner / Operator Contact Address
Arden Medical Ltd, --Arden Road, ALGESTER, WARKS,, GB-NOTA B49 6HN, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Urias

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-02-25
FZF Splint, Extremity, Inflatable, External General, Plastic Surgery Class 1 878.3900 2001-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

ARDEN MEDICAL 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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003516784. Last updated year: 2026. Please use registration number 3003516784 when referencing this establishment in official correspondence.
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