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Organization name
UDI-DI code
Reference / catalog number

Boreas Ice Gel 150 ml — Class I MDD by Frescon Oy

MD Atlas
Frescon Oy

EUDAMED last updated this device on Jul 14, 2025

Boreas Ice Gel 150 ml

B-1003BF4

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Frescon Oy
UDI-DI code: D-1003BF4
Reference / catalog number: 1003B

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Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: Boreas Ice Gel 150 ml
UDI-DI code: D-1003BF4
Basic UDI-DI: B-1003BF4
Reference / catalog number: 1003B
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ice gel is applied on the skin in order to decrease the temperature on the applied area. Treatment reduces muscle and joint pain, reduces swelling and triggers muscle tension. Device models: #1003B
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

Related devices

Boreas Ice Gel Roll-On 75 mlB-1002BEZOn the market Boreas Pain Relief CreamB-1007BFGOn the market Cool-X Cold GelB-10039COn the market Cool-X Cold Gel 50 mlB-10099QOn the market Cool-X Cold Gel 500 mlB-10049EOn the market

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.