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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

65.003.00 — Class I MDR by C.O.I. Compagnia Ottica…

MD Atlas
C.O.I. Compagnia Ottica Italiana srl

EUDAMED last updated this device on Aug 7, 2025

65.003.00

805384055COIZ12120199JX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: C.O.I. Compagnia Ottica Italiana srl
UDI-DI code: 08053840550060
Reference / catalog number: 65.003.00

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View device family (Basic UDI)

Manufacturer information

Organization name: C.O.I. Compagnia Ottica Italiana srl
SRN: IT-MF-000021292
Manufacturer status: Active

Related devices

54.030.68805384055COIZ12120199JXOn the market 66.013.00805384055COIZ12120199JXOn the market 76.010.00805384055COIZ12120199JXOn the market 62.011.01805384055COIZ12120199JXOn the market 62.041.07 805384055COIZ12120199JXOn 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 Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08053840550060
Basic UDI-DI: 805384055COIZ12120199JX
Reference / catalog number: 65.003.00
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: in scatola di legno - stecca con prismi con base verticale: 15 prismi (1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 25, 30 dptp) - stecca con prismi con base orizzontale: 16 prismi (1, 2, 4, 6, 8, 10, 12, 14,16, 18, 20, 25, 30, 35, 40, 45 dptp) - utilizzabili con tutti i test polarizzati quali i vectogrammi.
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

EMDN nomenclature code(s)

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

Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – 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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