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Organization name
UDI-DI code
Reference / catalog number

Medicare Hot & Cold Back Brace — Class I MDR by Fleming Medical

MD Atlas
Fleming Medical

EUDAMED last updated this device on Mar 24, 2026

Medicare Hot & Cold Back Brace

5099390HocopaRS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Medical
UDI-DI code: 05099390410174
Reference / catalog number: MD483

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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
This product contains natural rubber latex and neoprene which may cause allergic reactions or skin irritations in some inviduals. if rash develops or pain persists or increases,discontinue use and consult your 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: Medicare Hot & Cold Back Brace
UDI-DI code: 05099390410174
Basic UDI-DI: 5099390HocopaRS
Reference / catalog number: MD483
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: Hot and Cold Back Therapy Brace that is adjustable (26" - 50" waists). Cold therpy helps treat swelling,sprains,strains and bruising. Hot therpy helps relieve stiffness and fatique and relax tight muscles.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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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