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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

RS00VEI06 — Class IIb MDR by Regensight srl

MD Atlas
Regensight srl

EUDAMED last updated this device on Jan 31, 2026

RS00VEI06

805384861RSVEI0638

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Regensight srl
UDI-DI code: 08053848610018
Reference / catalog number: RS00VEI06

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View device family (Basic UDI)

Manufacturer information

Organization name: Regensight srl
SRN: IT-MF-000026392
Manufacturer status: Active

Related devices

RS00VEI07805384861RSVEI073AOn the market C4V CHROMO4VIS805384861RSVEI0332On the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2265967 1Issued
Quality management systemNotified body: 1936Expiry: Apr 29, 2030
EPT 0477.MDR.24/5691Issued
Quality management systemNotified body: 0477Expiry: Dec 22, 2029

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 31, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053848610018
Basic UDI-DI: 805384861RSVEI0638
Reference / catalog number: RS00VEI06
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08053848610018

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Q0299OPHTHALMIC DEVICES - 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

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