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Lipo Foam Sheet 8 Inch X 11 X 0.5 Inch (3 / Pkg)
EUDAMEDClass I (EU MDR)
Ref 91300003
Identity
- Trade Name
- LIPO FOAM SHEET 8 INCH X 11 X 0.5 INCH (3 / PKG) EUDAMED
- Device Name
- Compression Wear EUDAMED
- Model / Reference
- 91300003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00000091300003 EUDAMED
- Basic UDI-DI
- 6289992345789FY EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Lipo Foam Sheet 8 Inch X 11 X 0.5 Inch (3 / Pkg) by ClearPoint Medical Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6289992345789FY | Class I | Active |
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Manufacturer
- Manufacturer
- ClearPoint Medical Inc.
- EUDAMED SRN
- CA-MF-000037311
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 8c50c2c2-ace2-4f64-a8dc-1fbf15619ca7 61 fields · synced Jul 9, 2026