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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

02971 — Class IIb MDD by MONTEFARMACO OTC SPA

MD Atlas
MONTEFARMACO OTC SPA

EUDAMED last updated this device on May 6, 2022

02971

B-IRIDINA7T

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MONTEFARMACO OTC SPA
UDI-DI code: D-IRIDINA7T
Reference / catalog number: 02971

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View device family (Basic UDI)

Manufacturer information

Organization name: MONTEFARMACO OTC SPA
SRN: IT-MF-000013309
Manufacturer status: Active

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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

4 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW011
Il prodotto è solo per uso oftalmico esterno

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Apr 25, 2019	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-IRIDINA7T
Basic UDI-DI: B-IRIDINA7T
Reference / catalog number: 02971
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: Sterile solution for ophthalmic use with a physiological pH, containing sodium hyaluronate.
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-IRIDINA7T

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.

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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