Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

1100 M STP — IVDD — General IVDD by Diagnotix B.V.

MD Atlas
Diagnotix B.V.

EUDAMED last updated this device on Jun 9, 2022

1100 M STP

B-1100MSTPK7

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-1100MSTPK7
Reference / catalog number: 1100 M STP

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

4010 P AEDB-4010PAEDGJOn the market Anti-Epileptic Drugs Expanded Panel Reagent SetB-4030PAEDX4TOn the market 4300 P ABXB-4300PABXJPOn the market 4280 P AMMB-4280PAMMMROn the market 4240 P BZDB-4240PBZDLXOn the market

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

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

CW267
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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-1100MSTPK7
Basic UDI-DI: B-1100MSTPK7
Reference / catalog number: 1100 M STP
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 assessment of steroid profiles by determination of the levels of a panel of steroids in serum, 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.

W0102060203CORTISOL
W0102050115CORTICOSTERON (R/M)
W010205011411-DESOXYCORTISOL
W0102050110TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
W010205010717 OH PROGESTERONE
W0102050106PROGESTERONE
W0102050102DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
W0102050101ANDROSTENEDIONE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas