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Organization name
UDI-DI code
Reference / catalog number

04028694000386 — Class IIa MDD by TRB Chemedica AG

MD Atlas
TRB Chemedica AG

EUDAMED last updated this device on Mar 27, 2026

04028694000386

B-04028694000386

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: TRB Chemedica AG
UDI-DI code: 04028694000386
Reference / catalog number: 04028694000386

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Manufacturer information

Organization name: TRB Chemedica AG
SRN: DE-MF-000006919
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
Contra-Indications: Individual hypersensitivity to any constituent of the product. Precautions: Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of the opened container. Any solution not used immediately after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not use REMOGEN® OMEGA if the aluminium pouch or the containers are damaged. Store between 2 °C und 8 °C! Do not use REMOGEN® OMEGA after the expiry date indicated on the container and the folding box. This period refers to the product kept in the refrigerator (2 °C – 8 °C). Outside the refrigerator, the product has a shelf-life of 3 months if stored at a temperature below 25 °C and in its original packaging. Keep the product away from light, storing the single-dose containers in the aluminium pouch. If discomfort persists while using REMOGEN® OMEGA consult a physician. Keep out of reach of children.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04028694000386
Basic UDI-DI: B-04028694000386
Reference / catalog number: 04028694000386
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: REMOGEN® OMEGA – Microemulsion of polyunsaturated fatty acids and hydrating polymers. Lubricant eye drops. Sterile, free from preservatives.
Additional information URL: https://www.trbchemedica.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030399OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

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

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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.