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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

ONEO — Class I MDR by ATOL GROUP

MD Atlas
ATOL GROUP

EUDAMED last updated this device on May 13, 2024

ONEO

37016711FRPTY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ATOL GROUP
UDI-DI code: 03701671100156
Reference / catalog number: OFT801S M S P Framboise et cuivre

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Manufacturer information

Organization name: ATOL GROUP
SRN: FR-MF-000037164
Manufacturer status: Active

Related devices

ONEO37016711FRPTYOn the market ONEO37016711FRPTYOn the market ONEO37016711FRPTYOn the market ONEO37016711FRPTYOn the market ONEO37016711FRPTYOn 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 France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: ONEO
UDI-DI code: 03701671100156
Basic UDI-DI: 37016711FRPTY
Reference / catalog number: OFT801S M S P Framboise et cuivre
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: OFT801S M S P Framboise et cuivre
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02100202PLASTIC 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
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Software identification