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Organization name
UDI-DI code
Reference / catalog number

Radian Ice cold gel 50 ml — Class IIa MDR by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Apr 13, 2026

Radian Ice cold gel 50 ml

642061571350143B6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06420615711155
Reference / catalog number: 745009

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Manufacturer information

Organization name: Galena Pharma Oy
SRN: FI-MF-000000588
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.

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Apr 15, 2026	Still on market

Device identification

Trade name: Radian Ice cold gel 50 ml
UDI-DI code: 06420615711155
Basic UDI-DI: 642061571350143B6
Reference / catalog number: 745009
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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
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Software identification