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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

Topcon Signal — Class I MDR by Optomed Oyj

MD Atlas
Optomed Oyj

EUDAMED last updated this device on Nov 11, 2022

Topcon Signal

643004626cradle19T7F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Optomed Oyj
UDI-DI code: 06430046260849
Reference / catalog number: 41001596

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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: Topcon Signal
UDI-DI code: 06430046260849
Basic UDI-DI: 643004626cradle19T7F
Reference / catalog number: 41001596
Issuing entity: GS1

Classification

Risk category: Class I
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)

Z119080VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

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