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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

A0505 / CCOM-0003 — Class I MDR by HELIX SURGICAL SAS

MD Atlas
HELIX SURGICAL SAS

EUDAMED last updated this device on Dec 8, 2023

A0505 / CCOM-0003

++G162PATIENTINTERFACEDR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HELIX SURGICAL SAS
UDI-DI code: +G162A05050
Reference / catalog number: A0505 / CCOM-0003

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Manufacturer information

Organization name: HELIX SURGICAL SAS
SRN: FR-MF-000009344
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: +G162A05050
Basic UDI-DI: ++G162PATIENTINTERFACEDR
Reference / catalog number: A0505 / CCOM-0003
Issuing entity: HIBCC

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: Sterile optical interface to be used with ophtalmologic laser Rx
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011017NEODYMIUM SURGICAL LASER

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

IDEM-0001++G162RXC8On the market DCOM-0001++G162RXC8On the market RX++G162RXC8On 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.