Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

400630 — IVDD — Self-testing IVDD by NanoRepro AG

MD Atlas
NanoRepro AG

EUDAMED last updated this device on Nov 11, 2024

400630

B-400630MJ

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: NanoRepro AG
UDI-DI code: D-400630MJ
Reference / catalog number: 400630

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?

Manufacturer information

Organization name: NanoRepro AG
SRN: DE-MF-000023735
Manufacturer status: Active

Related devices

924203B-924203QEOn the market CeliacDetectB-400444MKOn the market Co-TEST KELIAKIATESTIB-400650MQOn the market DEODOC VagiQUICKB-500270MPOn the market 924207B-924207QNOn 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Slovenia; available across 1 country total.

Placed on the market in Slovenia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-400630MJ
Basic UDI-DI: B-400630MJ
Reference / catalog number: 400630
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Immunochromatographic rapid test for self-testing for the qualitative determination of anti-tTG IgA antibodies in human whole blood samples
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification