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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

2426 — Class IIa MDR by Evidencio

MD Atlas
Evidencio

EUDAMED last updated this device on Nov 27, 2024

2426

872029952642426RH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Evidencio
UDI-DI code: 08719327522776
Reference / catalog number: 2426

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View device family (Basic UDI)

Manufacturer information

Organization name: Evidencio
SRN: NL-MF-000008386
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	Jun 12, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08719327522776
Basic UDI-DI: 872029952642426RH
Reference / catalog number: 2426
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: The device is intended to be used by physicians to estimate the risk of 30-day acute myocardial infarction (AMI) in patients presenting with chest pain at the emergency department. The device uses results of a Troponin I measurement at presentation and its absolute 1h change to calculate the risk of AMI within 30 days.
Additional information URL: https://evidencio.com/manuals
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)08719327522776

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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.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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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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.