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Organization name
UDI-DI code
Reference / catalog number

Boreas Ice Gel Roll-On 75 ml — Class I MDD by Frescon Oy

MD Atlas
Frescon Oy

EUDAMED last updated this device on Jan 28, 2024

Boreas Ice Gel Roll-On 75 ml

B-1002BEZ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Frescon Oy
UDI-DI code: D-1002BEZ
Reference / catalog number: 1002B

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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.

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

Device identification

Trade name: Boreas Ice Gel Roll-On 75 ml
UDI-DI code: D-1002BEZ
Basic UDI-DI: B-1002BEZ
Reference / catalog number: 1002B
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. [EN]
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 150 mlB-1003BF4On 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.