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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

Ergomy Total — Class I MDR by Frestems Oy

MD Atlas
Frestems Oy

EUDAMED last updated this device on Aug 22, 2025

Ergomy Total

6429810491F000104PT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Frestems Oy
UDI-DI code: 06429810491114
Reference / catalog number: 38075

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Manufacturer information

Organization name: Frestems Oy
SRN: FI-MF-000001837
Manufacturer status: Active

Related devices

Ergomy Basic6429810491F000104PTOn the market Ergomy Carbon6429810491F000107PZOn the market 410626429810491F000104PTOn the market 340006429810491F000104PTOn the market 369316429810491F000107PZOn the market

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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Read manual before use

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Sweden		Still on market

Device identification

Trade name: Ergomy Total
UDI-DI code: 06429810491114
Basic UDI-DI: 6429810491F000104PT
Reference / catalog number: 38075
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0805038001RIGID SUPPORTS FOR LIFTS (STRETCHERS)

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
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Software identification