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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

Organic corrective glass with… — Class I MDR by Alcom d.o.o.

MD Atlas
Alcom d.o.o.

EUDAMED last updated this device on May 27, 2026

Organic corrective glass with dioptry

383007999ACMJN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alcom d.o.o.
UDI-DI code: 03830079990127
Reference / catalog number: Acomoda, Single Vision, Relax

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View device family (Basic UDI)

Manufacturer information

Organization name: Alcom d.o.o.
SRN: SI-MF-000004685
Manufacturer status: Active

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Bifocal with dioptry383007999BIFJXOn the market Monofocal mineral ophthalmic lenses383007999MSVNLOn the market Monofocal organic ophthalmic lenses383007999SPONTOn the market Organic corrective glass with dioptry383007999ISVMYOn the market Organic corrective glass with dioptry383007999SSVPJOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement	May 25, 2026	Still on market

Device identification

Trade name: Organic corrective glass with dioptry
UDI-DI code: 03830079990127
Basic UDI-DI: 383007999ACMJN
Reference / catalog number: Acomoda, Single Vision, Relax
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: Enožariščno steklo z dioptrijo
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)03830079990127

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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.

Q0210010101MONOFOCAL ORGANIC OPHTHALMIC LENSES

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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