ISO 13485 and ISO 9001 certificates
Our quality management certificates, with the register links to check them yourself.
Verify onlineRegistration support
Registration support, market by market.
In most markets a laryngoscope must meet the local medical device rules before it is sold. Depending on the market, it is registered by the manufacturer, an authorised representative or the local importer or distributor. Choose your market to see what it asks for, and get our documents for your file in one request.
- 01Choose your market31 markets on our export map.
- 02See what it asks forFramework, authority and labelling language.
- 03Tick the documents you needOne request; our quality team answers within 2 working days.
Africa
Americas
Asia-Pacific
Europe
Middle East
Choose a market on the left.
Framework lines describe each market for your reference; they are not a statement that a product is registered there. A dot marks markets where one of our own registrations applies.
The documents
What we provide for your file.
Sent with every quotation, and on request at any time.
EU declaration of conformity
Signed declarations under Regulation (EU) 2017/745, with the Basic UDI-DI and class of each device.
RequestInstructions for use (IFU)
For every product family: use, cleaning and reprocessing of reusable devices, disposal of single-use devices.
RequestSpecification sheets
Materials, light, sizes, codes and compatibility of each product, as a PDF.
DownloadReprocessing guidance
How reusable blades and handles are cleaned, disinfected and sterilised, step by step.
ReadTender documents checklist
The documents tenders usually ask for, so nothing holds up your submission.
ReadQuestions
Asked about registration.
Who registers a laryngoscope in my country?
It depends on the market. In the European Union the manufacturer registers in EUDAMED, and a manufacturer outside the EU names an EU Authorised Representative. In many other markets the local importer or distributor holds the registration. Choose your market on this page to see its framework.
Is Long Life Surgical registered in EUDAMED?
Yes. Our single registration number (SRN) as a manufacturer is PK-MF-000010701. EU Authorised Representative: MDSS GmbH, Hannover (SRN DE-AR-000005430). You can check it in EUDAMED on ec.europa.eu.
Is Long Life Surgical registered with the US FDA?
Yes. We hold an FDA establishment registration and device listing, registration number 3013901429. You can check it in the FDA database; our verification centre shows how.
Which documents do you provide for a registration file?
ISO 13485 and ISO 9001 certificates, EU declarations of conformity, instructions for use (IFU), specification sheets, reprocessing guidance and a tender documents checklist. They are sent with every quotation and on request.
Can you provide a Free Sale Certificate or legalised documents?
Tell us exactly what your authority asks for, and our quality team replies within 2 working days with what we can provide.
Your authority asks for something else?
Some authorities also ask for a Free Sale Certificate, a letter of authorisation or legalised copies. Tell us exactly what your authority asks for, and we will tell you what we can provide.