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Physiologix Ultimate Carpal Tunnel Brace
EUDAMEDClass I (EU MDR)
Ref PX3515Ref PX306L
Identity
- Trade Name
- Physiologix Ultimate Carpal Tunnel Brace EUDAMED
- Device Name
- Sport Support EUDAMED
- Model / Reference
- PX3515 EUDAMEDPX306L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390417005 EUDAMED05099390415476 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 Ultimate Carpal Tunnel Brace 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fleming Medical
- EUDAMED SRN
- IE-MF-000044303
Sources (2)
- EUDAMED 215ee78b-1c01-4fd5-a25b-f0ddc8c8f11f 61 fields · synced Aug 4, 2026
- EUDAMED 71fb7b7a-05b3-4ea2-a0fe-735df27c648d 61 fields · synced May 16, 2026