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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

4160 P CAR — IVDD — General IVDD by Diagnotix B.V.

MD Atlas
Diagnotix B.V.

EUDAMED last updated this device on Jun 9, 2022

4160 P CAR

B-4160PCARKW

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Diagnotix B.V.
UDI-DI code: D-4160PCARKW
Reference / catalog number: 4160 P CAR

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View device family (Basic UDI)

Manufacturer information

Organization name: Diagnotix B.V.
SRN: NL-MF-000000236
Manufacturer status: Active

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Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW264
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.

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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: not provided
UDI-DI code: D-4160PCARKW
Basic UDI-DI: B-4160PCARKW
Reference / catalog number: 4160 P CAR
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The intended use (medical purpose) of this device is to aid in the Therapeutic Drug Monitoring (TDM)of several cardiac medications by determination of these medications in plasma, performed by automated quantitative LC-MS/MS assay technology.
Additional information URL: https://www.diagnotix.com/
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.

W0102080199CARDIOVASCULAR TDM - OTHER
W0102080105LIDOCAINE
W0102080104FLECAINIDE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.