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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

Optomed Aurora camera — Class I MDD by Optomed Oyj

MD Atlas
Optomed Oyj

EUDAMED last updated this device on Aug 19, 2025

Optomed Aurora camera

B-06430046260702

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Optomed Oyj
UDI-DI code: 06430046260702
Reference / catalog number: 41000650

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Manufacturer information

Organization name: Optomed Oyj
SRN: FI-MF-000009407
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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: Optomed Aurora camera
UDI-DI code: 06430046260702
Basic UDI-DI: B-06430046260702
Reference / catalog number: 41000650
Issuing entity: GS1

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z119003BIOIMAGING PHOTOGRAPHY INSTRUMENTS

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

Optomed AuroraB-06430046260795On the market Optomed AuroraB-06430046260719On the market Optomed AuroraB-06430046260726On the market Optomed AuroraB-06430046260757On the market Optomed Aurora643004626cradle19C3On the market

Certificates

Certificate health across this manufacturer's portfolio.

FI24/00000061refdata.certificate-status.reissued
Quality management systemNotified body: 0598Expiry: Jun 16, 2030
FI24/00000061Supplemented
Quality management systemNotified body: 0598Expiry: Jun 5, 2029