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Organization name
UDI-DI code
Reference / catalog number

013-00082 — Class IIa MDD by Sensatronic GmbH

MD Atlas
Sensatronic GmbH

EUDAMED last updated this device on Jul 21, 2025

013-00082

B-04260651380920

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Sensatronic GmbH
UDI-DI code: 04260651380920
Reference / catalog number: 013-00082

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Manufacturer information

Organization name: Sensatronic GmbH
SRN: DE-MF-000004927
Manufacturer status: Active

Related devices

013-00163426065138TDEC9ROn the market 013-00162426065138TDEC9ROn the market 013-00081B-04260651380913On the market 013-00080B-04260651380906On the market 011-01405B-04260651380449On 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

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

CW009
Single-use product.
CW999
Do not place the skin temperature probe in areas with injured skin, open wounds or lesions.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 21, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260651380920
Basic UDI-DI: B-04260651380920
Reference / catalog number: 013-00082
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Skin single-use temperature probe
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V03010201TEMPERATURE MONITORING CUTANEOUS PROBES

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