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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

Sensara — Class IIb MDR by Sensara B.V.

MD Atlas
Sensara B.V.

EUDAMED last updated this device on Jan 8, 2026

Sensara

872089285100SC-0001DB

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sensara B.V.
UDI-DI code: 87208928510024
Reference / catalog number: SC-0001

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View device family (Basic UDI)

Manufacturer information

Organization name: Sensara B.V.
SRN: NL-MF-000050450
Manufacturer status: Active

Related devices

Sensara72089285100SC-0001Z6On the market SC000110074797SC-0001WKOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Apr 1, 2027	Apr 1, 2037

Device identification

Trade name: Sensara
UDI-DI code: 87208928510024
Basic UDI-DI: 872089285100SC-0001DB
Reference / catalog number: SC-0001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: SensaraConnect is an independent Medical Device Software (MDSW) designed to monitor physiological processes and activities of daily living (ADL) of elderly residents in care facilities. The system provides information to support clinical decision-making for diagnostic and therapeutic purposes.
Additional information URL: https://www.sensara.eu/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING 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

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