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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

ThIR-A615 — Class I MDD by TherMidas Oy

MD Atlas
TherMidas Oy

EUDAMED last updated this device on Dec 4, 2025

ThIR-A615

B-ThIR-A615XR

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: TherMidas Oy
UDI-DI code: D-ThIR-A615XR
Reference / catalog number: ThIR-A615

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Manufacturer information

Organization name: TherMidas Oy
SRN: FI-MF-000007644
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-ThIR-A615XR
Basic UDI-DI: B-ThIR-A615XR
Reference / catalog number: ThIR-A615
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: TherMidas IR System is thermal imaging system for measuring and monitoring changes in skin surface temperature non-invasively. The intended purpose of the infrared imaging device includes the areas of diabetic foot, suspected skin neoplasms, skin grafts, arthritis, and pressure injuries. Application areas in diabetic foot cover e.g., vascular disorders, diabetic foot ulcers and skin microcirculation.
Additional information URL: https://www.thermidas.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z119013THERMOGRAPHS

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

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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.