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Organization name
UDI-DI code
Reference / catalog number

VisOcu — Class IIb MDR by Phibio GmbH

MD Atlas
Phibio GmbH

EUDAMED last updated this device on Aug 27, 2025

VisOcu

425090620HA-OVDUG

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Phibio GmbH
UDI-DI code: 04250906200080
Reference / catalog number: PHI301DE-VSO

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Manufacturer information

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

Critical warnings

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

CW011
Caution
CW010
See instructions for use
CW009
Do not re-use
CW001
Do not re-sterilise

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
EL		Still on market
France		Still on market

Device identification

Trade name: VisOcu
UDI-DI code: 04250906200080
Basic UDI-DI: 425090620HA-OVDUG
Reference / catalog number: PHI301DE-VSO
Issuing entity: GS1

Classification

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

Device details

Quantity: 50
Additional product description: Opthalmic Viscosurgical Device
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES

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

Certificate health across this manufacturer's portfolio.

1TD-MDR-0076/10/2025Issued
Technical documentationNotified body: 2764Expiry: Oct 1, 2028
2QMS-MDR-0076/10/2025Issued
Quality management systemNotified body: 2764Expiry: Oct 1, 2028
1TD-MDR-0076/10/2025Withdrawn
Technical documentationNotified body: 2764Expiry: Oct 1, 2028
6QMS-MDR-0076/06/2025Issued
Quality management systemNotified body: 2764Expiry: Jun 11, 2030