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Organization name
UDI-DI code
Reference / catalog number

Ortholand Cross 2.5% — Class III MDR by Phibio GmbH

MD Atlas
Phibio GmbH

EUDAMED last updated this device on Mar 4, 2026

Ortholand Cross 2.5%

42509062IACS6

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Phibio GmbH
UDI-DI code: 04250906203425
Reference / catalog number: PHI253DE-ORTC

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Manufacturer information

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

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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: Ortholand Cross 2.5%
UDI-DI code: 04250906203425
Basic UDI-DI: 42509062IACS6
Reference / catalog number: PHI253DE-ORTC
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
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

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