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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

SenseLink — Class IIa MDR by TeMeCo B.V.

MD Atlas
TeMeCo B.V.

EUDAMED last updated this device on Dec 23, 2025

SenseLink

87202997353SenseLinkDC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TeMeCo B.V.
UDI-DI code: 08720299735378
Reference / catalog number: SL01

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View device family (Basic UDI)

Manufacturer information

Organization name: TeMeCo B.V.
SRN: NL-MF-000011503
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Sep 7, 2017	Still on market

Device identification

Trade name: SenseLink
UDI-DI code: 08720299735378
Basic UDI-DI: 87202997353SenseLinkDC
Reference / catalog number: SL01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: System consisting of SenseLink recorder, ECG leads (3-lead, 5-lead, 12-lead) and associated software applications
Additional information URL: https://www.temeco.nl/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08720299735378

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Z12050403ECG HOLTER RECORDERS

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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

21M00198CRT01Issued
Quality management systemNotified body: 1912Expiry: Sep 29, 2027