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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

ViscoPhi 1.6% — Class III MDR by Phibio GmbH

MD Atlas
Phibio GmbH

EUDAMED last updated this device on Mar 17, 2026

ViscoPhi 1.6%

42509062IALSQ

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Phibio GmbH
UDI-DI code: 04250906200646
Reference / catalog number: PHI162DE-VSP

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Manufacturer information

Organization name: Phibio GmbH
SRN: DE-MF-000045435
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Nov 1, 2025	Nov 1, 2029

Device identification

Trade name: ViscoPhi 1.6%
UDI-DI code: 04250906200646
Basic UDI-DI: 42509062IALSQ
Reference / catalog number: PHI162DE-VSP
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterile Viscoelastic Gel Implant %0.005mg Sodium Dihydrogen Phosphate %0.015mg Di Sodium Hydrogen Phosphate %0.9mg Sodium Chloride 16mg/ml Sodium Hyaluronate
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.