EUDAMED last updated this device on Jun 25, 2026

ophthafutur hpmc

B-04260260050283

On the marketClass IIb

Applicable legislation: —
Organization name: Pharmpur GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260260050283
Reference / catalog number: 500518

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ophthafutur hpmc is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Pharmpur GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ophthafutur hpmc
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260260050283
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. View in glossary →: B-04260260050283
Reference / catalog number: 500518
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.ophthafutur.de/
Clinical sizes: 2 ml

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04260260050283

EMDN nomenclature code(s)

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

Q02030399OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

Critical warnings

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

Consult instructions for use
Do not re-use
Do not resterilize
Do not use if package is damaged
Do not use past indicated date
This product should only be used by professional users, who are familiar with the use of such a product. Precautions are the same as those associated with this type of surgical procedures. Injection of excessive amounts of ophthafutur hpmc 2 % may increase intraocular pressure (IOP) tempo-rarily. 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 sur-gery, all remaining ophthafutur hpmc 2 % should be re-moved 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. ▻ Content is only sterile if the sterile barrier is unopened and undamaged. ▻ Do not use after expiration date. ▻ Single use only. With topical use of ophthafutur hpmc 2 %, e.g. in the go-nioscopy, the vision can temporarily slightly decrease due to the occurrence of streaks. Make sure that ophthafutur hpmc 2 % does not dry.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 31 countries total.

Country	On market since	Until
GermanyPrimary placement	Apr 20, 2011	Still on market
Austria	Apr 20, 2011	Still on market
Belgium	Apr 20, 2011	Still on market
Bulgaria	Apr 20, 2011	Still on market
Cyprus	Apr 20, 2011	Still on market
Czechia	Apr 20, 2011	Still on market
Denmark	Apr 20, 2011	Still on market
Estonia	Apr 20, 2011	Still on market
EL	Apr 20, 2011	Still on market
Spain	Apr 20, 2011	Still on market
Finland	Apr 20, 2011	Still on market
France	Apr 20, 2011	Still on market
Croatia	Apr 20, 2011	Still on market
Hungary	Apr 20, 2011	Still on market
Ireland	Apr 20, 2011	Still on market
Iceland	Apr 20, 2011	Still on market
Italy	Apr 20, 2011	Still on market
Liechtenstein	Apr 20, 2011	Still on market
Lithuania	Apr 20, 2011	Still on market
Luxembourg	Apr 20, 2011	Still on market
Latvia	Apr 20, 2011	Still on market
Malta	Apr 20, 2011	Still on market
Netherlands	Apr 20, 2011	Still on market
Norway	Apr 20, 2011	Still on market
Poland	Apr 20, 2011	Still on market
Portugal	Apr 20, 2011	Still on market
Romania	Apr 20, 2011	Still on market
Sweden	Apr 20, 2011	Still on market
Slovenia	Apr 20, 2011	Still on market
Slovakia	Apr 20, 2011	Still on market
XI	Apr 20, 2011	Still on market

Related searches

Class IIb medical devices in EUDAMED

Device identification

Trade name: ophthafutur hpmc
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260260050283
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. View in glossary →: B-04260260050283
Reference / catalog number: 500518
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Critical warnings

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

Consult instructions for use
Do not re-use
Do not resterilize
Do not use if package is damaged
Do not use past indicated date
This product should only be used by professional users, who are familiar with the use of such a product. Precautions are the same as those associated with this type of surgical procedures. Injection of excessive amounts of ophthafutur hpmc 2 % may increase intraocular pressure (IOP) tempo-rarily. 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 sur-gery, all remaining ophthafutur hpmc 2 % should be re-moved 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. ▻ Content is only sterile if the sterile barrier is unopened and undamaged. ▻ Do not use after expiration date. ▻ Single use only. With topical use of ophthafutur hpmc 2 %, e.g. in the go-nioscopy, the vision can temporarily slightly decrease due to the occurrence of streaks. Make sure that ophthafutur hpmc 2 % does not dry.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 31 countries total.

Country	On market since	Until
GermanyPrimary placement	Apr 20, 2011	Still on market
Austria	Apr 20, 2011	Still on market
Belgium	Apr 20, 2011	Still on market
Bulgaria	Apr 20, 2011	Still on market
Cyprus	Apr 20, 2011	Still on market
Czechia	Apr 20, 2011	Still on market
Denmark	Apr 20, 2011	Still on market
Estonia	Apr 20, 2011	Still on market
EL	Apr 20, 2011	Still on market
Spain	Apr 20, 2011	Still on market
Finland	Apr 20, 2011	Still on market
France	Apr 20, 2011	Still on market
Croatia	Apr 20, 2011	Still on market
Hungary	Apr 20, 2011	Still on market
Ireland	Apr 20, 2011	Still on market
Iceland	Apr 20, 2011	Still on market
Italy	Apr 20, 2011	Still on market
Liechtenstein	Apr 20, 2011	Still on market
Lithuania	Apr 20, 2011	Still on market
Luxembourg	Apr 20, 2011	Still on market
Latvia	Apr 20, 2011	Still on market
Malta	Apr 20, 2011	Still on market
Netherlands	Apr 20, 2011	Still on market
Norway	Apr 20, 2011	Still on market
Poland	Apr 20, 2011	Still on market
Portugal	Apr 20, 2011	Still on market
Romania	Apr 20, 2011	Still on market
Sweden	Apr 20, 2011	Still on market
Slovenia	Apr 20, 2011	Still on market
Slovakia	Apr 20, 2011	Still on market
XI	Apr 20, 2011	Still on market

ophthafutur hpmc

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Legacy certificates

Related devices

Certificates covering this device

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