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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

EUALMNSM025P — Class IIb MDR by Nirial Pharma srl

MD Atlas
Nirial Pharma srl

EUDAMED last updated this device on May 26, 2026

EUALMNSM025P

805299063OFTA001MA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Nirial Pharma srl
UDI-DI code: 08052990632541
Reference / catalog number: EUALMNSM025P

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View device family (Basic UDI)

Manufacturer information

Organization name: Nirial Pharma srl
SRN: IT-MF-000018760
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

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

CW010
EUDAMED did not publish a description for this code.
CW277
If you experience any adverse reactions, stop taking the product immediately, consult your doctor and inform the manufacturer.
CW032
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW275
If you are pregnant or breastfeeding, please consult your doctor first.
CW999
Interactions with medicines: No interactions with medicines are known. Other ophthalmic products (medicines or medical devices) must be used at least 15 minutes after instilling these eye drops. Oral administration of other medical devices, medicines or supplements in conjunction with these eye drops must be carried out under the supervision of a doctor. Contraindications: Known sensitivity or allergy to any ingredient. Precautions and warnings: The product is for use by a single person only. Do not use the product if you are aware of any incompatibility with even a single component of the formulation. Do not use the product in the event of hypersensitivity or a confirmed allergy to one or more components. Any serious incident occurring in connection with the device must be reported promptly to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established. Keep out of the reach and sight of children. Use in children must be supervised by an adult. Do not swallow. For external use only. For ophthalmic use only.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement	Mar 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08052990632541
Basic UDI-DI: 805299063OFTA001MA
Reference / catalog number: EUALMNSM025P
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)08052990632541

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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.

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - 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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