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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

IS2002 — Class I MDR by ISIS - INTELLIGENT…

MD Atlas
ISIS - INTELLIGENT SURGICAL INSTRUMENTS & SYSTEMS

EUDAMED last updated this device on Apr 23, 2026

IS2002

3770022348IS5004RC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ISIS - INTELLIGENT SURGICAL INSTRUMENTS & SYSTEMS
UDI-DI code: 03770022348530
Reference / catalog number: IS2002

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Manufacturer information

Organization name: ISIS - INTELLIGENT SURGICAL INSTRUMENTS & SYSTEMS
SRN: FR-MF-000009585
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770022348530
Basic UDI-DI: 3770022348IS5004RC
Reference / catalog number: IS2002
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: Permet de piloter les fonctions principales de coupoles d’éclairage de champs opératoire.
Additional information URL: https://cdn.prod.website-files.com/6007194674a8b2ae9db99dda/68ba9a30b2df81a4d96a7060_IfU%20eclairage%20op%C3%A9ratoire%20g%C3%A9n%C3%A9rique_EN.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

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.