Quality & compliance
Facts over claims. Regulation over decoration.
A laryngoscope is used at the most critical moment of an anaesthetic. We treat its quality the same way: documented, inspected and traceable, with every certificate open to independent checking.
Certificates and registrations
Every credential, checkable.
Each certificate and registration links to the official register that holds it. You do not need to ask us; you can check it yourself in a few minutes.
Regulatory status by market
What applies where, in plain words.
Rigid laryngoscopes are generally low-risk, class I devices in the European Union and the United States. That decides who certifies what.
| Market | Framework | Our status | Check it |
|---|---|---|---|
| European Union | Regulation (EU) 2017/745 (MDR), class I. | Manufacturer registered in EUDAMED, with an EU authorised representative. CE marking under our EU declaration of conformity. | EUDAMED |
| United States | 21 CFR 868.5540, rigid laryngoscope, class I, product code CCW, exempt from 510(k). | Establishment registration and device listing with the FDA, renewed every year. | FDA database |
| Saudi Arabia | SFDA Medical Device Marketing Authorization (MDMA). | Marketing authorization for the Saudi market. | SFDA list |
| All markets | ISO 13485:2016 and ISO 9001:2015 quality management systems. | Certified by an independent certification body. | IAF CertSearch |
The class of each device is stated in its EU declaration of conformity.
How we control quality
Inspected at every step, recorded for every batch.
Quality is not a department at the end of the line. It is built into how material is received, how blades are formed and finished, and how every product is checked before it is packed.
- 01
Incoming material
Steel, brass, optical components and packaging checked against specification before use.
Material certificates - 02
In-process checks
Dimensions, fit and finish verified during forming, machining and polishing.
Dimensions to drawing - 03
Light and function
Blades and handles tested for illumination and a secure lock on the fitting.
Light on · lock tested - 04
Final inspection
Surfaces, edges and markings inspected before cleaning and packing.
Visual and marking check - 05
Traceability
A lot number on every pack, linked to the production and inspection records.
Lot to record
Documents
Everything your registration or tender file needs.
Sent with every quotation, and on request at any time.
Certificates
ISO 13485 and ISO 9001 certificates, with the register links to check them.
Verification centerEU declaration of conformity
Signed declarations under Regulation (EU) 2017/745, with the Basic UDI-DI and class of each device.
RequestInstructions for use
IFUs for every product family: use, cleaning and reprocessing of reusable devices, disposal of single-use devices.
RequestSpecification sheets
Every product page prints as a clean specification sheet: materials, light, sizes and compatibility.
Find a productReprocessing guidance
How reusable blades and handles are cleaned, disinfected and sterilised, step by step.
Read the guideTender checklist
The documents tenders usually ask for, market by market, so nothing holds up your submission.
Read the checklistWarning: single-use blades and handles must not be reprocessed or reused. Always follow the instructions for use supplied with the device.
Need documents for a tender?
Tell us the tender requirements, and we will send what your file needs.