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Organization name
UDI-DI code
Reference / catalog number

350143/665001 — Class IIa MDR by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Jun 30, 2025

350143/665001

642061571350143B6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06420615711001
Reference / catalog number: 350143/665001

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Manufacturer information

Organization name: Galena Pharma Oy
SRN: FI-MF-000000588
Manufacturer status: Active

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350221/426001642061571350221AZOn the market 426002B-426002NFOn the market 9272084B-06418086102169On the market 9259071B-06418086101902On the market 9294700B-06418086102428On the market

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jun 30, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06420615711001
Basic UDI-DI: 642061571350143B6
Reference / catalog number: 350143/665001
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: To relieve pain and swelling of soft tissues, muscles and joints related to sprains, strains and sport injuries. After exercise, to relieve muscle soreness and help muscle to recover.
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

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1162-806-22Supplemented
Quality management systemNotified body: 0537Expiry: Jun 30, 2027