Organization name

Pharmpur GmbH

SRN

DE-MF-000008337

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use past indicated date
• Do not use if package is damaged
• Injection of excessive amounts of ophthafutur hpmc 2 % may increase intraocular pressure (IOP) temporarily. An excessive IOP may also be caused by a pre-existing glaucoma condition, by reduced outflow, and by operative procedures and their aftereffects. Because these factors vary from case to case and are difficult to predict, the following precautions are recommended: Do not overfill the eye with ophthafutur hpmc 2 %. At the end of surgery, all remaining ophthafutur hpmc 2 % should be removed by irrigation and/or aspiration. Carefully monitor the IOP, especially during the immediate post-operative period. In case that a significant increase of IOP is observed, treat appropriately. Avoid the injection of an air bubble at the end of the surgery.

  OTHER

• With topical use of ophthafutur hpmc 2 %, e.g. in the gonioscopy, the vision can temporarily slightly decrease due to the occurrence of streaks. Make sure that ophthafutur hpmc 2 % does not dry.

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

Visco 4500

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04260260050535

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-04260260050535

Reference / catalog number

500069

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Viscoelastic

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.

• Q02030399OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.