Identity
- Trade Name
- Physiologix Foam Underwrap EUDAMED
- Device Name
- Underwrap Foam EUDAMED
- Model / Reference
- MD763 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390407389 EUDAMED
- Basic UDI-DI
- 5099390UnderfoamXZ EUDAMED
- EMDN Code
- M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Physiologix Foam Underwrap by Fleming Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5099390UnderfoamXZ | Class I | Active |
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Manufacturer
- Manufacturer
- Fleming Medical
- EUDAMED SRN
- IE-MF-000044303
Sources (1)
- EUDAMED d75d1a7b-d467-40e4-b2fa-99c0575efca0 61 fields · synced Sep 17, 2026