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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

2187 — Class IIa MDR by Evidencio

MD Atlas
Evidencio

EUDAMED last updated this device on Nov 27, 2024

2187

872029952642187RN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Evidencio
UDI-DI code: 08720299526402
Reference / catalog number: 2187

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View device family (Basic UDI)

Manufacturer information

Organization name: Evidencio
SRN: NL-MF-000008386
Manufacturer status: Active

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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.

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: 08720299526402
Basic UDI-DI: 872029952642187RN
Reference / catalog number: 2187
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 ABC Stroke Risk Score Calculator is developed to support clinical decision making by informing clinical management on the estimated risk that an individual patient, diagnosed with atrial fibrillation or atrial flutter, may suffer a stroke or systemic embolism within the next 1, 2, or 3 years.
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)08720299526402

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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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