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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

OP80ALR002 — Class IIb MDD by ITALDEVICE S.R.L.

MD Atlas
ITALDEVICE S.R.L.

EUDAMED last updated this device on Feb 4, 2025

OP80ALR002

B-ITMF26487OP80ALR00239

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ITALDEVICE S.R.L.
UDI-DI code: D-ITMF26487OP80ALR00239
Reference / catalog number: OP80ALR002

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View device family (Basic UDI)

Manufacturer information

Organization name: ITALDEVICE S.R.L.
SRN: IT-MF-000026487
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030103-00Issued
Quality management systemNotified body: 0425Expiry: Nov 5, 2029

Critical warnings

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

CW275
Do not use the product if you are allergic to or have a known hypersensitivity to any of its ingredients; • In the event of serious corneal diseases, before use, consult your physician

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jun 19, 2021	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-ITMF26487OP80ALR00239
Basic UDI-DI: B-ITMF26487OP80ALR00239
Reference / catalog number: OP80ALR002
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sample 3 ml
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

D-ITMF26487OP80ALR00239

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

Q02030206EYE LUBRICANT SOLUTIONS

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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