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

CardiolyseECGSoftware — Class IIa MDD by Cardiolyse Oy

MD Atlas
Cardiolyse Oy

EUDAMED last updated this device on Oct 14, 2022

CardiolyseECGSoftware

B-CardiolyseECGsoftwareBH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Cardiolyse Oy
UDI-DI code: D-CardiolyseECGsoftwareBH
Reference / catalog number: CardiolyseECGSoftware

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: Cardiolyse Oy
SRN: FI-MF-000017174
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Oct 1, 2020	Still on market

Device identification

Trade name: CardiolyseECGSoftware
UDI-DI code: D-CardiolyseECGsoftwareBH
Basic UDI-DI: B-CardiolyseECGsoftwareBH
Reference / catalog number: CardiolyseECGSoftware
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CardiolyseECGSoftware
Additional information URL: https://www.cardiolyse.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030682VITAL SIGNS TELEMETRY INSTRUMENTS - SOFTWARE 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

This device is not currently linked to any other device.

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.