FDA.report

Mepore®

Primary DI
07333350625993
Brand
Mepore®
Company
Mölnlycke Health Care AB
Model
332000
Device description
Mepore Roll 7cmx5m
Published
2026-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333350149383PackageGS118In Commercial Distribution
07333350625993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333350149383073333501493837333350149383
07333350625993073333506259937333350625993

GMDN Terms

TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Contacts

PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags

DUNS number
631770658
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07333350764944Mepilex® Lite2845992026-01-25

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