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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) radiopaque lead… — Class I MDR by Fysicon B.V.

MD Atlas
Fysicon B.V.

EUDAMED last updated this device on Aug 5, 2024

10 Lead (AHA) radiopaque lead wire set with grabber

8719689142QMAPPCONSKJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysicon B.V.
UDI-DI code: 08720254542331
Reference / catalog number: 01567033

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View device family (Basic UDI)

Manufacturer information

Organization name: Fysicon B.V.
SRN: NL-MF-000002694
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		Still on market

Device identification

Trade name: 10 Lead (AHA) radiopaque lead wire set with grabber
UDI-DI code: 08720254542331
Basic UDI-DI: 8719689142QMAPPCONSKJ
Reference / catalog number: 01567033
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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Related devices

Leadset (10 pcs) IEC, Grabber, Radiopaque (4 Limb 130cm - 6 Chest 70cm)8719689142QMAPPCONSKJOn the market 01853004 Reusable NiBP Cuff, Adult (Grey), 23-33 cm (01)087196891424908719689142QMAPPCONSKJOn the market 01853006 Reusable NiBP Cuff, Large Adult (Burgundy), 31-40 cm (01)087196891425138719689142QMAPPCONSKJOn the market 01853008 Reusable NiBP Cuff, Thigh (Brown), 38-50 cm (01)087196891425378719689142QMAPPCONSKJOn the market 10 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 10x120 cm8719689142QMAPPCONSKJOn the market

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