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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

Leadset (10 pcs) IEC, Grabber,… — Class I MDR by Fysicon B.V.

MD Atlas
Fysicon B.V.

EUDAMED last updated this device on Nov 27, 2023

Leadset (10 pcs) IEC, Grabber, Radiopaque (4 Limb 130cm - 6 Chest 70cm)

8719689142QMAPPCONSKJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysicon B.V.
UDI-DI code: 08719689142209
Reference / catalog number: 01567002

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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: Leadset (10 pcs) IEC, Grabber, Radiopaque (4 Limb 130cm - 6 Chest 70cm)
UDI-DI code: 08719689142209
Basic UDI-DI: 8719689142QMAPPCONSKJ
Reference / catalog number: 01567002
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

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 10 Lead (AHA) radiopaque lead wire set with grabber8719689142QMAPPCONSKJOn 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