ANZEN HEALTH

FDA Device Registration & Listing · Chicago, IL, US · Registration 3017235663

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
3017235663
FEI Number
3017235663
Entity Name
ANZEN HEALTH
City/State/Country
Chicago, IL, US
Establishment Address
4245 N. Knox Ave., #801, Chicago, IL 60641, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Anzen Health (Owner Number: 10078168)
Owner / Operator Contact Address
4245 N. Knox Ave., Chicago, IL 60641, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Cap Disposable Isolation Gown AIZOME Healthcare Bedding Disposable Medical Face Mask Disposable Shoe Cover Surgical apparel AIZOME Healthcare Towels

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2025-05-01
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2025-05-01
QTV Mattress And Bed Deck Cover (Medical Purposes) General Hospital Class 1 880.6190 2024-01-12
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2026-03-11
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2025-05-01
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2024-01-12
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-01-12

Official Correspondent

Michel May

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Anzen Health
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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017235663. Last updated year: 2026. Please use registration number 3017235663 when referencing this establishment in official correspondence.
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