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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

SC0001 — Class IIb MDR by Sensara B.V.

MD Atlas
Sensara B.V.

EUDAMED last updated this device on Nov 18, 2025

SC0001

10074797SC-0001WK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sensara B.V.
UDI-DI code: 87208928510000
Reference / catalog number: SC0001

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View device family (Basic UDI)

Manufacturer information

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

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	Feb 1, 2038

Device identification

Trade name: not provided
UDI-DI code: 87208928510000
Basic UDI-DI: 10074797SC-0001WK
Reference / catalog number: SC0001
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 a software system for alarming and communication in care
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.

Y215199ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - 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

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Related devices

Sensara872089285100SC-0001DBOn the market Sensara72089285100SC-0001Z6On 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.