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Organization name
UDI-DI code
Reference / catalog number

Cool-X Hot-Cold Compress — Class I MDR by Frescon Oy

MD Atlas
Frescon Oy

EUDAMED last updated this device on Jan 31, 2024

Cool-X Hot-Cold Compress

6430019200087RL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Frescon Oy
UDI-DI code: 06430019200087
Reference / catalog number: 1031

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Manufacturer information

Organization name: Frescon Oy
SRN: FI-MF-000017377
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW136
May cause frostbite or burns if it is placed directly to the skin. Persons with impaired circulation should not use the cold pack. Consult a doctor if symptoms persist for a long time. Do not use a broken pack. Keep out of the reach of children. Do not use on broken skin. For external use only.
CW135
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Cool-X Hot-Cold Compress
UDI-DI code: 06430019200087
Basic UDI-DI: 6430019200087RL
Reference / catalog number: 1031
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: Reusable Hot / Cold compress for cold and thermal therapy.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.