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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

7468942 — Class IIb MDR by Penta Arzneimittel GmbH

MD Atlas
Penta Arzneimittel GmbH

EUDAMED last updated this device on May 29, 2026

7468942

426059553MP06UD01KF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Penta Arzneimittel GmbH
UDI-DI code: 14260595533182
Reference / catalog number: 7468942

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View device family (Basic UDI)

Manufacturer information

Organization name: Penta Arzneimittel GmbH
SRN: DE-MF-000006565
Manufacturer status: Active

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Critical warnings

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

CW007
Do not use the product if single dose container is damaged.
CW032
Do not use the eye drops beyond the expiry date which you can find on each single dose container and on each folding box.
CW010
Consult instructions for use.
CW036
If you also use other eye drops / eye ointment, wait about 15 minutes. These eye drops should always be used last.
CW135
The eye drops are filled into small plastic containers which could be swallowed by small children. Therefore, please keep the product out of the reach of children.
CW137
Do not use in infected and injured eyes.
CW008
Do not touch the eye with the single dose container.
CW129
Do not use if you are allergic to any of the ingredients.
CW304
In very rare cases, the use of the eye drops may cause irritation in very sensitive eyes or eye lids. The following eye disorders may occur: redness, pain, burning, stinging, itching, swelling, foreign body sensation.
CW011
Temporary blurring for a brief period may be experienced after application; avoid driving, operating machinery and wait until normal vision is restored.
CW277
In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 14260595533182
Basic UDI-DI: 426059553MP06UD01KF
Reference / catalog number: 7468942
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: Hypromellose 0.3% Eye Drops (single dose container, 0.5ml) care for and moisturise the ocular surface and alleviate the symptoms of Dry Eye Syndrome.
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)14260595533182

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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.

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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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.