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ActivHeal

FDA UDI

Class U (US FDA UDI)

by Advanced Medical Solutions Limited

Identity

Trade Name
ActivHeal FDA UDI
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Device Name
AQUAFIBER Ag SILVER Alginate 5X5CM FDA UDI
Model / Reference
Silver Alginate FDA UDI
Description
AQUAFIBER Ag SILVER Alginate 5X5CM FDA UDI

Identifiers

Catalog Number
9023236 FDA UDI
Primary DI / UDI-DI
15032749023233 FDA UDI
510(k) Number
K080503 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

ActivHeal by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.

Cleared under the same submission

K080503 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Solutions Limited

Sources (1)

  • FDA UDI 24e7dd9a-09fd-4bb1-a8ef-3204505e56ea 35 fields · synced Jun 8, 2026