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Physiologix Essential Ankle Support
EUDAMEDClass I (EU MDR)
Ref PX100XLRef PX100LG
Identity
- Trade Name
- Physiologix Essential Ankle Support EUDAMED
- Device Name
- Sport Support EUDAMED
- Model / Reference
- PX100XL EUDAMEDPX100LG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390415001 EUDAMED05099390414974 EUDAMED
- Basic UDI-DI
- 5099390SportSZH EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER 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
Yes
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: Compression/pressure sock/stocking, reusable
Physiologix Essential Ankle Support by Fleming Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5099390SportSZH | Class I | Active |
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Manufacturer
- Manufacturer
- Fleming Medical
- EUDAMED SRN
- IE-MF-000044303
Sources (2)
- EUDAMED 83663b3c-acc3-4f20-b7b1-70b7400fa4b9 61 fields · synced Jul 10, 2026
- EUDAMED fc7778ad-d0fe-42f7-9c73-40c72ba38ae8 61 fields · synced May 18, 2026