Identity
- Trade Name
- Amekina FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- Amekina Skin and Wound Spray FDA UDI
- Model / Reference
- 200 ML Spray FDA UDI
- Description
- Amekina Skin and Wound Spray FDA UDI
Identifiers
- Catalog Number
- 419842 FDA UDI
- Primary DI / UDI-DI
- 00898021000372 FDA UDI
- 510(k) Number
- K082858 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Antimicrobial wound irrigation solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Antimicrobial wound irrigation solution
Amekina by Angelini Pharma Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antimicrobial wound irrigation solution.
- Puracyn® Plus Professional Formula — Innovacyn, Inc. · U
- Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE — ARGENTUM MEDICAL, LLC · U
- Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with f — ARGENTUM MEDICAL, LLC · U
- ELECTROCYN soma — V3Bio Sdn. Bhd · U
- Shield Products — Digital Ally, Inc. · U
- BIAKOS™ Antimicrobial Skin & Wound Cleanser — Sanara Medtech Inc. · U
- Anasept Antimicrobial Skin and Wound Cleanser — Anacapa Technologies, Inc. · Class II
- Prontosan® — B. BRAUN MEDICAL INC. · U
Cleared under the same submission
K082858 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angelini Pharma Inc.
Sources (1)
- FDA UDI 2c25d985-77db-458e-a75d-949b7b1d453c 37 fields · synced Jun 9, 2026