EUDAMED last updated this device on Feb 22, 2024

iLESSYS® FHD Laminoscope (3.7 WCh), ocular

B-04250337105763

On the marketClass IIa

Applicable legislation: —
Organization name: Joimax GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04250337105763
Reference / catalog number: LS6342125O

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

iLESSYS® FHD Laminoscope (3.7 WCh), ocular is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Joimax GmbH. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: iLESSYS® FHD Laminoscope (3.7 WCh), ocular
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04250337105763
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-04250337105763
Reference / catalog number: LS6342125O
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Working Channel OD 3.7 mm
Irrigation Channel 1.5 mm
125 MU50
6.3 MU50
30 MU105

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04250337105763

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12021199ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER

Critical warnings

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

Refer to instruction manual/booklet

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 19 countries total.

Country	On market since	Until
ItalyPrimary placement	May 28, 2015	Still on market
Austria	Jan 29, 2016	Still on market
Belgium	May 28, 2015	Still on market
Bulgaria	May 31, 2013	Still on market
Czechia	May 28, 2015	Still on market
Germany	May 28, 2015	Still on market
Denmark	May 28, 2015	Still on market
EL	May 28, 2015	Still on market
Spain	Feb 5, 2019	Still on market
France	May 28, 2015	Still on market
Croatia	May 28, 2015	Still on market
Ireland	May 28, 2015	Still on market
Luxembourg	May 28, 2015	Still on market
Netherlands	May 28, 2015	Still on market
Norway	May 28, 2015	Still on market
Poland	May 31, 2013	Still on market
Portugal	May 31, 2013	Still on market
Romania	May 31, 2013	Still on market
Türkiye	May 31, 2013	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: iLESSYS® FHD Laminoscope (3.7 WCh), ocular
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04250337105763
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-04250337105763
Reference / catalog number: LS6342125O
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

G10 049319 0007Supplemented
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: TÜV SÜD Product Service GmbH (0123)Expiry: Jan 31, 2029
G11 049319 0011Issued
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: TÜV SÜD Product Service GmbH (0123)Expiry: Feb 4, 2029

Market distribution

Primary placement in Italy; available across 19 countries total.

Country	On market since	Until
ItalyPrimary placement	May 28, 2015	Still on market
Austria	Jan 29, 2016	Still on market
Belgium	May 28, 2015	Still on market
Bulgaria	May 31, 2013	Still on market
Czechia	May 28, 2015	Still on market
Germany	May 28, 2015	Still on market
Denmark	May 28, 2015	Still on market
EL	May 28, 2015	Still on market
Spain	Feb 5, 2019	Still on market
France	May 28, 2015	Still on market
Croatia	May 28, 2015	Still on market
Ireland	May 28, 2015	Still on market
Luxembourg	May 28, 2015	Still on market
Netherlands	May 28, 2015	Still on market
Norway	May 28, 2015	Still on market
Poland	May 31, 2013	Still on market
Portugal	May 31, 2013	Still on market
Romania	May 31, 2013	Still on market
Türkiye	May 31, 2013	Still on market

iLESSYS® FHD Laminoscope (3.7 WCh), ocular

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

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