FDA Registration
Active
🇺🇸 United States
ANZEN HEALTH
Reg #: 3017235663
·
FEI: 3017235663
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- ANZEN HEALTH
- Registration Number
- 3017235663
- FEI Number
- 3017235663
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4245 N. Knox Ave., #801
- City
- Chicago
- State
- IL
- ZIP
- 60641
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182514
Owner / Operator
- Firm Name
- Anzen Health
- Operator Number
- 10078168
- Address
- 4245 N. Knox Ave.
- City
- Chicago
- State
- IL
- Postal Code
- 60641
- Country
- US
- Correspondent
- Michel May
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2025-05-01 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2025-05-01 |
| Mattress And Bed Deck Cover (Medical Purposes) | QTV | Class 1 | General Hospital | No | 2024-01-12 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2026-03-11 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2025-05-01 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2024-01-12 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-01-12 |
Proprietary Names
Disposable Cap
Disposable Isolation Gown
AIZOME Healthcare Bedding
Disposable Medical Face Mask
Disposable Shoe Cover
Surgical apparel
AIZOME Healthcare Towels
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility