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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

10 Lead (AHA) Radiolucent Lead… — Class I MDR by Fysicon B.V.

MD Atlas
Fysicon B.V.

EUDAMED last updated this device on Jul 10, 2025

10 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 10x120 cm

8719689142QMAPPCONSKJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysicon B.V.
UDI-DI code: 08720938410208
Reference / catalog number: 01077304

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Manufacturer information

Organization name: Fysicon B.V.
SRN: NL-MF-000002694
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

24M00192CRT01Reissued
Quality management systemNotified body: 1912Expiry: Mar 14, 2030
24M00192CRT01Reissued
Quality management systemNotified body: 1912Expiry: Mar 14, 2030
21M00066CRT02Amended
Quality management systemNotified body: 1912Expiry: Mar 14, 2025

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: 10 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 10x120 cm
UDI-DI code: 08720938410208
Basic UDI-DI: 8719689142QMAPPCONSKJ
Reference / catalog number: 01077304
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: N/A
Additional information URL: No additional information URL provided by the manufacturer.
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.

Z12050785INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES

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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