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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

BDM161 — Class I MDR by NOKI Kereskedelmi és…

MD Atlas
NOKI Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

EUDAMED last updated this device on Dec 12, 2022

BDM161

599957378Q02100201WP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NOKI Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
UDI-DI code: 05999573780301
Reference / catalog number: BDM161

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Manufacturer information

Organization name: NOKI Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
SRN: HU-MF-000027260
Manufacturer status: Active

Related devices

BDM140599957378Q02100201WPOn the market BDM141599957378Q02100201WPOn the market BDM142599957378Q02100201WPOn the market BDM143599957378Q02100201WPOn the market BDM144599957378Q02100201WPOn the market

Market distribution

Primary placement in Hungary; available across 2 countries total.

Country	On market since	Until
HungaryPrimary placement		Still on market
Romania		Still on market

Device identification

Trade name: BDM161
UDI-DI code: 05999573780301
Basic UDI-DI: 599957378Q02100201WP
Reference / catalog number: BDM161
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Metal Spectacle Frames Without Lenses The frame is an essential accessory so that the optical lenses can be carried and compensate for a visual defect.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02100201METAL SPECTACLE FRAMES WITHOUT LENSES

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

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.