Product description:
Torch/flashlight, pre-focused for medical use to look down the throat.
Material: Heavy-walled plastic case of metal case.
Right-angled head type
Splash waterproof, sealed with o-ring.
Lamp head approx. 40mm.
Sturdy long-lasting mechanical switch.
Light bulb 2.5 V Xenon.
Batteries required, 2 x standard alkaline, dry cell batteries (type AA, 1.5V).
Supplied with:
- one spare light bulb (2.5V Xenon).
- 2 x standard alkaline, dry cell batteries (type AA, 1.5V), separately.
Instructions for use:
Flashlight for medical use to look down the throat.
For providing additional lighting during diagnosis examinations.
Safety process:
This item must be cleaned and disinfected after each use.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use
One (1) flashlight in a box of case, with Manufacturer's instruction for use, spare parts and accessories (when applicable).
Labelling displays, at least: Product name, reference number, manufacturer's name and address, CE mark of similar, lot number of batch number, UDI (if MDR certified), use-by-date, symbol for Medical device
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223
CE mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
Must comply with the following standards:
IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $41.45 |
