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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

Metanephrines Reagent Set — IVDD — Annex II List B IVDD

MD Atlas
Diagnotix B.V.

EUDAMED last updated this device on Jan 18, 2022

Metanephrines Reagent Set

B-08720514311721

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Diagnotix B.V.
UDI-DI code: 08720514311721
Reference / catalog number: 1060 M MET

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

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: Metanephrines Reagent Set
UDI-DI code: 08720514311721
Basic UDI-DI: B-08720514311721
Reference / catalog number: 1060 M MET
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Reagent kit for the determination of metanephrine, normetanephrine and 3-MT in plasma, for LC/MS assay use.
Additional information URL: https://www.diagnotix.com/en/downloadcenter/manuals
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.

W0102090204CATECHOLAMINES

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.