L-Mesitran Border

FDA UDI

Class U (US FDA UDI)

by Theo Manufacturing B.V.

Identity

Trade Name: L-Mesitran Border FDA UDI
Generic Name: Wound hydrogel dressing, antimicrobial FDA UDI
Device Name: L-Mesitran Border dressings are hydro-active hydrogel wound dressings containing honey. FDA UDI
Model / Reference: 518.10.US FDA UDI
Description: L-Mesitran Border dressings are hydro-active hydrogel wound dressings containing honey. FDA UDI

Identifiers

Primary DI / UDI-DI: 08717249680765 FDA UDI
510(k) Number: K053613 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound hydrogel dressing, 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wound hydrogel dressing, antimicrobial

L-Mesitran Border by Theo Manufacturing B.V. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound hydrogel dressing, antimicrobial.

Pure&Clean — Pure & Clean, LLC · U
EltaMD SilverGel 1.5 oz — CP Skin Health Group, Inc. · U
BlastX™ — Next Science LLC · U
Silver-sept Silver Antimicrobial Skin and Wound Gel — Anacapa Technologies, Inc. · U
ProCure — Twin Med, LLC · U
Armor Gel — Abl Medical, LLC · U
Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
Carestat — American Biotech Labs · U

Cleared under the same submission

K053613 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 U	Pending data

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Manufacturer

Manufacturer: Theo Manufacturing B.V.

Sources (1)

FDA UDI 8cdbad5a-18ae-4da3-9f1a-60aae676588c 34 fields · synced Jun 1, 2026