REMEDIUM HEALTHCARE PRODUCTS

FDA Device Registration & Listing · Northbrook, IL, US · Registration 3029875292

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
3029875292
FEI Number
3029875292
Entity Name
REMEDIUM HEALTHCARE PRODUCTS
City/State/Country
Northbrook, IL, US
Establishment Address
40 Skokie Blvd Ste 260, Northbrook, IL 60062, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Remedium Healthcare Products (Owner Number: 10088714)
Owner / Operator Contact Address
40 Skokie Blvd., Suite 235, Northbrook, IL 60062, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Remedium Homecare Mattress

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IKY Mattress, Flotation Therapy, Non-Powered General Hospital Class 1 880.5150 2026-05-04
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-11-15
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2023-11-20

Official Correspondent

Vladamir Anastasov

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Remedium Healthcare Products
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
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029875292. Last updated year: 2026. Please use registration number 3029875292 when referencing this establishment in official correspondence.
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