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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

350221/426001 — Class IIb MDR by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Jan 20, 2026

350221/426001

642061571350221AZ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06420615711032
Reference / catalog number: 350221/426001

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Manufacturer information

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

Related devices

426002B-426002NFOn the market 9272084B-06418086102169On the market 9259071B-06418086101902On the market 9294700B-06418086102428On the market 9289816B-06418086102374On the market

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Jan 20, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06420615711032
Basic UDI-DI: 642061571350221AZ
Reference / catalog number: 350221/426001
Issuing entity: GS1

Classification

Risk category: Class IIb
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)

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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