Identity
- Trade Name
- Mepilex Border Flex Lite EUDAMEDMepilex® Border Flex Lite FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Mepilex Border Flex Lite/EM EUDAMEDMepilex Border Flex Lite 4x5cm FDA UDI
- Model / Reference
- 581011 EUDAMEDFDA UDI
- Description
- Mepilex Border Flex Lite 4x5cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07323190249466 EUDAMEDFDA UDI
- Basic UDI-DI
- 733243000000000073K3 EUDAMED
- FDA Product Code
- NAC FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex® Border Flex Lite by Mölnlycke Health Care AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (2)
- FDA UDI b422fa00-0cd3-499e-8bd8-fcbfe56e44ee 35 fields · synced Oct 10, 2026
- EUDAMED 55618bb8-b07b-4af3-bfd8-b60da62db4f4 61 fields · synced Oct 10, 2026