41112900

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• CW007

  Do not use the product if the safety ring of the tamper evident closure is broken or the bottle is damaged.
• CW032

  Do not use the eye drops beyond the expiry date which you can find on each multi-dose container and on the 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.
• CW999

  Due to the special innovative sterile filter system of the dropper insert a small quantity always remains in the bottle. To ensure unrestricted dropping capability, regular use is recommended.
• CW135

  Please keep the product out of reach of children.
• CW137

  Do not use in infected eyes.
• CW008

  Do not touch the eye with the dropper.
• 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.

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

14260595532192

Basic UDI-DI

426059553MP18OSD012F

Reference / catalog number

41112900

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% - Malva Sylvestris Eye Drops (multi dose container, 10ml) refreshes, moisturises and soothes dry and irritated eyes.

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