Mepitac®

FDA UDI

Class I (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name: Mepitac® FDA UDI
Generic Name: Dressing-fixation skin adhesive tape, silicone FDA UDI
Device Name: Mepitac 0,8inx3,3yd/2cmx3m, CVS FDA UDI
Model / Reference: 298488 FDA UDI
Description: Mepitac 0,8inx3,3yd/2cmx3m, CVS FDA UDI

Identifiers

Primary DI / UDI-DI: 07323190176557 FDA UDI
FDA Product Code: KGX FDA UDI
GMDN Term: Dressing-fixation skin adhesive tape, silicone FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 0.0 Millimeter FDA UDI
Width — 0.0 Millimeter FDA UDI
Length — 0.0 Millimeter FDA UDI

Category: Dressing-fixation skin adhesive tape, silicone

Mepitac® by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dressing-fixation skin adhesive tape, silicone.

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McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
FifthPulse — Jeg & Sons Inc. · Class I
OFFSET MODULAR HEAD PROVISIONAL — Biomet Orthopedics, Inc. · Class I
Acanthus — ACANTHUS MEDICAL CREATIONS, LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Mölnlycke Health Care AB

Sources (1)

FDA UDI 850a03b4-5c6e-4d9e-b1b5-43cdd93672fb 34 fields · synced Jun 6, 2026