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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

34004/425116 — Class IIa MDR by Galena Pharma Oy

MD Atlas
Galena Pharma Oy

EUDAMED last updated this device on Mar 11, 2025

34004/425116

642061571340044AQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Galena Pharma Oy
UDI-DI code: 06420615710868
Reference / catalog number: 34004/425116

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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

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 Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Mar 31, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06420615710868
Basic UDI-DI: 642061571340044AQ
Reference / catalog number: 34004/425116
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)

Q030499OTOLOGY DEVICES - OTHER

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