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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

0500100001 — Class IIb MDR by Novaliq GmbH

MD Atlas
Novaliq GmbH

EUDAMED last updated this device on Jan 10, 2023

0500100001

426074112NVG00129

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Novaliq GmbH
UDI-DI code: 04260741121013
Reference / catalog number: 0500100001

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Manufacturer information

Organization name: Novaliq GmbH
SRN: DE-MF-000009618
Manufacturer status: Active

Critical warnings

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

CW161
Es liegen noch keine Daten zur Sicherheit bei Schwangeren, Stillenden und Kindern vor, daher wird die Anwendung von NovaTears® hier nicht empfohlen.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 20, 2014	Still on market
Austria	Jan 20, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260741121013
Basic UDI-DI: 426074112NVG00129
Reference / catalog number: 0500100001
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

0500300001426074112NVG00129On 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.