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Organization name
UDI-DI code
Reference / catalog number

BDM160 — 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

BDM160

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: 05999573780295
Reference / catalog number: BDM160

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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

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.

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: BDM160
UDI-DI code: 05999573780295
Basic UDI-DI: 599957378Q02100201WP
Reference / catalog number: BDM160
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
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Software identification