41013501

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• 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.
• 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. Important information for users with severe corneal damage: In very rare cases, deposits of calcium phosphate on the cornea have been reported during the use of phosphate-containing eye drops.
• 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.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

14260595530952

Basic UDI-DI

426059553MP01UD01HQ

Reference / catalog number

41013501

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sodium Hyaluronate 0.15% Eye Drops (single dose container, 0.35ml) 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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES