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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

13500 — Class IIa MDD by Newmars Technologies kft

MD Atlas
Newmars Technologies kft

EUDAMED last updated this device on Dec 14, 2023

13500

B-05999888051608

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Newmars Technologies kft
UDI-DI code: 05999888051608
Reference / catalog number: 13500

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Manufacturer information

Organization name: Newmars Technologies kft
SRN: HU-MF-000007115
Manufacturer status: Active

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement	Jun 23, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05999888051608
Basic UDI-DI: B-05999888051608
Reference / catalog number: 13500
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

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

EMDN nomenclature code(s)

W02020502CERVICAL SCREENING SYSTEMS

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

This device is not currently linked to any other device.

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.