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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

IOL-Robotics — Class IIa MDD by Juvaplus SA

MD Atlas
Juvaplus SA

EUDAMED last updated this device on Apr 28, 2022

IOL-Robotics

B-++EJUVIR01DK

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Juvaplus SA
UDI-DI code: ++EJUVIR01DK
Reference / catalog number: IR01

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Manufacturer information

Organization name: Juvaplus SA
SRN: CH-MF-000017503
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 2, 2022	Still on market

Device identification

Trade name: IOL-Robotics
UDI-DI code: ++EJUVIR01DK
Basic UDI-DI: B-++EJUVIR01DK
Reference / catalog number: IR01
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: IOL-robotics is intended to assist the surgeon to deliver Intraocular Lens into the eye following cataract removal.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

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

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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.