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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

VitalScan ANS (HW10) — Class IIa MDR by Medeia Group Ltd

MD Atlas
Medeia Group Ltd

EUDAMED last updated this device on Dec 5, 2025

VitalScan ANS (HW10)

197644300693HW10TH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medeia Group Ltd
UDI-DI code: 01976443006932
Reference / catalog number: VitalScan ANS (HW10)

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Manufacturer information

Organization name: Medeia Group Ltd
SRN: BG-MF-000025710
Manufacturer status: Active

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Feb 10, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 01976443006932
Basic UDI-DI: 197644300693HW10TH
Reference / catalog number: VitalScan ANS (HW10)
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: Heart Rate Variability and Pulse Wave Velocity Measurement Device for assessment of Cardiovascular and Autonomic Nervous System
Additional information URL: https://eifu.vitalscan.com/eu
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

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

Certificate health across this manufacturer's portfolio.

HU26/00000012Issued
Quality management systemNotified body: 1639Expiry: Feb 6, 2030
20M00006CRT01Withdrawn
Quality management systemNotified body: 1912Expiry: Feb 6, 2030