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Organization name
UDI-DI code
Reference / catalog number

F-Decalin - Syringe 5 ml — Class IIa MDR by FLUORON GmbH

MD Atlas
FLUORON GmbH

EUDAMED last updated this device on Mar 19, 2026

F-Decalin - Syringe 5 ml

4260160455065R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FLUORON GmbH
UDI-DI code: 04260160450336
Reference / catalog number: G-80115

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Manufacturer information

Organization name: FLUORON GmbH
SRN: DE-MF-000009235
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
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	Jan 12, 1999	Still on market

Device identification

Trade name: F-Decalin - Syringe 5 ml
UDI-DI code: 04260160450336
Basic UDI-DI: 4260160455065R
Reference / catalog number: G-80115
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030205OPHTHALMIC SURGERY, PERFLUOROCARBONS PURE AND COMBINED WITH OTHER SUBSTANCES

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

G-810104260160455025HOn the market G-810154260160455025HOn the market F-Decalin - Syringe 7 ml4260160455065ROn the market G-801054260160455065ROn the market G-801074260160455065ROn the market

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.