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Mepitel®

FDA UDI

Class II (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name
Mepitel® FDA UDI
Generic Name
Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
Device Name
Mepitel 7,5x10cm, US FDA UDI
Model / Reference
290799 FDA UDI
Description
Mepitel 7,5x10cm, US FDA UDI

Identifiers

Primary DI / UDI-DI
07310792907108 FDA UDI
510(k) Number
K161797 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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

No

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Category: Wound-nonadherent dressing, permeable, non-antimicrobial

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

Similar devices

Also classified as Wound-nonadherent dressing, permeable, non-antimicrobial.

Cleared under the same submission

K161797 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mölnlycke Health Care AB

Sources (1)

  • FDA UDI 83004774-e44e-4616-b47b-ee1f2decef06 36 fields · synced May 30, 2026