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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

GS Balance — Class IIa MDR by GS Balance Oy

MD Atlas
GS Balance Oy

EUDAMED last updated this device on Mar 17, 2026

GS Balance

643006792BAL16R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GS Balance Oy
UDI-DI code: 06430067920012
Reference / catalog number: GS Balance

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Manufacturer information

Organization name: GS Balance Oy
SRN: FI-MF-000021645
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jun 15, 2023	Still on market

Device identification

Trade name: GS Balance
UDI-DI code: 06430067920012
Basic UDI-DI: 643006792BAL16R
Reference / catalog number: GS Balance
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: Remote monitoring software product for chronic conditions.
Additional information URL: https://gsbalance.blob.core.windows.net/userdocs/balance_professional_userguide.pdf%20%20%20%20%20https://gsbalance.blob.core.windows.net/userdocs/balance_personal_userguide_en.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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.

CR-03-1198-837-24Amended
Quality management systemNotified body: 0537Expiry: May 2, 2028