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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

AMSWV10 — Class I MDD by Adamant Health Oy

MD Atlas
Adamant Health Oy

EUDAMED last updated this device on Jul 29, 2025

AMSWV10

B-FIMF000006598AMSWV107D

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Adamant Health Oy
UDI-DI code: D-FIMF000006598AMSWV107D
Reference / catalog number: AMSWV10

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Manufacturer information

Organization name: Adamant Health Oy
SRN: FI-MF-000006598
Manufacturer status: Active

Critical warnings

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

CW011
Do not use alone for diagnosis or treatment decisions.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-FIMF000006598AMSWV107D
Basic UDI-DI: B-FIMF000006598AMSWV107D
Reference / catalog number: AMSWV10
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: AH Analysis Module is intended for analysis of surface electromyographic and kinematic data measured from patients with conditions such as Parkinson's disease and myoclonus epilepsy. The information provided by the Analysis module is utilized in analysis of patient s motor symptoms. Information or analysis results are not intended to be used alone for diagnosis or treatment decisions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12100792EMG TELEMETRY 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

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.