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Organization name
UDI-DI code
Reference / catalog number

SteadySense Patch Sensitive — Class I MDR by SteadySense GmbH

MD Atlas
SteadySense GmbH

EUDAMED last updated this device on Mar 23, 2026

SteadySense Patch Sensitive

91200959PX01ND

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SteadySense GmbH
UDI-DI code: 09120095900434
Reference / catalog number: 09120095900434

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Manufacturer information

Organization name: SteadySense GmbH
SRN: AT-MF-000003984
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
The SteadySense Patch shall not be used in case of known allergies to ingredients of skin patches
CW027
Magnetic fields might damage the functionality of the patch (e.g.MR or CT-examinations)

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: SteadySense Patch Sensitive
UDI-DI code: 09120095900434
Basic UDI-DI: 91200959PX01ND
Reference / catalog number: 09120095900434
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: The SteadySense Patch Sensitive is single use adhesive body temperature measuring device, combining hardware and software components.
Additional information URL: https://www.steadytemp.health/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V030199BODY TEMPERATURE MEASURING DEVICES - OTHER

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.