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Organization name
UDI-DI code
Reference / catalog number

Physiologix Ultimate Carpal… — Class I MDR by Fleming Medical

MD Atlas
Fleming Medical

EUDAMED last updated this device on Mar 11, 2026

Physiologix Ultimate Carpal Tunnel Brace

5099390SportSZH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Medical
UDI-DI code: 05099390417005
Reference / catalog number: PX3515

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Manufacturer information

Organization name: Fleming Medical
SRN: IE-MF-000044303
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Before use always seek medical advice from your doctor. If the support is being used following a sprain seek medical advice if no improvement it seen within 72 hours. Always take advice on duration of use. Ensure product is not uncomfortably tight and blood flow is not restricted. Only use on clean intact skin. Do not use if you have a known allergy to any of the materials listed( Neoprene, Polyester, Nylon).The product should be applied as directed. If a rash develops, pain is prolonged or if no improvement in the condition is seen, discontinue use and consult a doctor.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: Physiologix Ultimate Carpal Tunnel Brace
UDI-DI code: 05099390417005
Basic UDI-DI: 5099390SportSZH
Reference / catalog number: PX3515
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Wrist Support helps relieve pain and discomfort associated with carpal tunnel syndrome and other wrist-related injuries. Designed for firm compression and superior support.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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