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EUDAMED last updated this device on Jul 7, 2026
B-00857580006133Endoscopic cable 4.8mm x 6ft is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Gulf Fiberoptics. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00857580006133Endoscopic cable 4.8mm x 6ft (01)00857580006133
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12029080VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES1 warning recorded — scroll inside the panel to see all entries.
This fiber optic endoscopic light cable transmits high-intensity light from a medical light source to an endoscope. During operation, the distal tip of the cable and connected endoscope components may reach elevated temperatures (up to approximately 41°C / 105.8°F) and can cause thermal injury if touched. The emitted light energy is capable of causing burns to tissue and skin, and may ignite flammable materials such as surgical drapes, plastics, or paper if improperly positioned. The light beam must never be directed toward eyes, as it can cause serious ocular injury. To prevent injury, allow the system to cool for at least five minutes after turning off the light source before handling or disconnecting the cable. Do not operate in the presence of combustible gases. This device is intended for use by trained medical professionals only and must be handled according to the manufacturer’s instructions.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
US-MF-000006301Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
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.