Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

F-Octane - Vial 7 ml — Class IIa MDR by FLUORON GmbH

MD Atlas
FLUORON GmbH

EUDAMED last updated this device on Mar 19, 2026

F-Octane - Vial 7 ml

4260160455065R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FLUORON GmbH
UDI-DI code: 04260160450527
Reference / catalog number: G-80307

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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-Octane - Vial 7 ml
UDI-DI code: 04260160450527
Basic UDI-DI: 4260160455065R
Reference / catalog number: G-80307
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 5 ml4260160455065ROn the market F-Decalin - Syringe 7 ml4260160455065ROn the market G-801054260160455065ROn 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.