Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

BCB Myeloma Register — Class IIa MDR by BCB Medical Oy

MD Atlas
BCB Medical Oy

EUDAMED last updated this device on Feb 11, 2023

BCB Myeloma Register

643007851BCBDSR2H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BCB Medical Oy
UDI-DI code: 06430078510264
Reference / catalog number: 06430078510264

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

BCB 15D Register643007851BCBDSR2HOn the market BCB Allergy diagnostics Register643007851BCBDSR2HOn the market BCB Asthma Register643007851BCBDSR2HOn the market BCB Bipolar disorder Register643007851BCBDSR2HOn the market BCB Bladder cancer Register643007851BCBDSR2HOn the market

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 Myeloma Register
UDI-DI code: 06430078510264
Basic UDI-DI: 643007851BCBDSR2H
Reference / catalog number: 06430078510264
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