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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

IBP Cable Medex Logical – CR… — Class I MDR by Fysicon B.V.

MD Atlas
Fysicon B.V.

EUDAMED last updated this device on Aug 5, 2024

IBP Cable Medex Logical – CR Bard, Boston Scientific (320CM)

8719689142QMAPPCONSKJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysicon B.V.
UDI-DI code: 08720938410123
Reference / catalog number: 01802042

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View device family (Basic UDI)

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: IBP Cable Medex Logical – CR Bard, Boston Scientific (320CM)
UDI-DI code: 08720938410123
Basic UDI-DI: 8719689142QMAPPCONSKJ
Reference / catalog number: 01802042
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

UDI-DI DataMatrix

Encoded

(01)08720938410123

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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.

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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