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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

4010 P AED — IVDD — General IVDD by Diagnotix B.V.

MD Atlas
Diagnotix B.V.

EUDAMED last updated this device on Jun 9, 2022

4010 P AED

B-4010PAEDGJ

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-4010PAEDGJ
Reference / catalog number: 4010 P AED

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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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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.

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-4010PAEDGJ
Basic UDI-DI: B-4010PAEDGJ
Reference / catalog number: 4010 P AED
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 anti-epileptic drugs by the determination of these anti-epileptic 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.

W0102080299CENTRAL NERVOUS SYSTEM TDM - OTHER
W0102080215LEVETIRACETAM
W0102080212LAMOTRIGINE
W0102080210VALPROIC ACID
W0102080208PHENYTOIN
W0102080207PHENOBARBITAL
W0102080202ETHOSUXIMIDE
W0102080201CARBAMAZEPINE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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