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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Physiologix Foam Underwrap — Class I MDR by Fleming Medical

MD Atlas
Fleming Medical

EUDAMED last updated this device on Mar 20, 2026

Physiologix Foam Underwrap

5099390UnderfoamXZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Medical
UDI-DI code: 05099390407389
Reference / catalog number: MD763

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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
If any irritation occurs discontinue use. Do not apply underwrap too tightly as it may cause restriction. Remove underwrap if numbness or tingling occurs, and re-apply less tightly.

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 Foam Underwrap
UDI-DI code: 05099390407389
Basic UDI-DI: 5099390UnderfoamXZ
Reference / catalog number: MD763
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: Sport foam underwrap(7cmx27m) is used for added comfort to prevent skin chaffing and for painless tape removal.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0303010101ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION

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

Batch number
Expiration date
Manufacturing date
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Software identification