← Back to catalogue

Mepitel® Film

FDA UDI

Class I (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name
Mepitel® Film FDA UDI
Generic Name
Synthetic polymer semi-permeable film dressing, wound-nonadherent FDA UDI
Device Name
Mepitel Film 10x25cm FDA UDI
Model / Reference
296470 FDA UDI
Description
Mepitel Film 10x25cm FDA UDI

Identifiers

Primary DI / UDI-DI
07332551974374 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Synthetic polymer semi-permeable film dressing, wound-nonadherent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Synthetic polymer semi-permeable film dressing, wound-nonadherent

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

Similar devices

Also classified as Synthetic polymer semi-permeable film dressing, wound-nonadherent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mölnlycke Health Care AB

Sources (1)

  • FDA UDI 44b4f6a6-530a-4266-8754-863d8391365f 35 fields · synced May 31, 2026