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Organization name
UDI-DI code
Reference / catalog number

BCB Retina Register — Class IIa MDR by BCB Medical Oy

MD Atlas
BCB Medical Oy

EUDAMED last updated this device on Feb 9, 2023

BCB Retina Register

643007851BCBDSR2H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BCB Medical Oy
UDI-DI code: 06430078510554
Reference / catalog number: 06430078510554

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Manufacturer information

Organization name: BCB Medical Oy
SRN: FI-MF-000002441
Manufacturer status: Active

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Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jan 23, 2023	Still on market

Device identification

Trade name: BCB Retina Register
UDI-DI code: 06430078510554
Basic UDI-DI: 643007851BCBDSR2H
Reference / catalog number: 06430078510554
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: The product is a SaaS Software product.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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.

FI23/0000002refdata.certificate-status.reissued
Quality management systemNotified body: 0598Expiry: Feb 11, 2031
FI23/0000002Supplemented
Quality management systemNotified body: 0598Expiry: Jan 22, 2027