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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

ONYX350 — Class I MDR by H & Z Distribution

MD Atlas
H & Z Distribution

EUDAMED last updated this device on May 13, 2026

ONYX350

377004217LOUPES-PLAST62

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: H & Z Distribution
UDI-DI code: 03770042179411
Reference / catalog number: ONYX350

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Manufacturer information

Organization name: H & Z Distribution
SRN: FR-MF-000053127
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jun 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770042179411
Basic UDI-DI: 377004217LOUPES-PLAST62
Reference / catalog number: ONYX350
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 3.5 MU104
53 MU50

EMDN nomenclature code(s)

Q0210030102READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC 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.

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