UKCA-certified medical device
Roliner is a prosthetic liner classified as a medical device. UKCA marking granted in December 2025 following assessment against the UK Medical Devices Regulations 2002.
Safety information
Safety, compliance, and travelling with your Roliner.
Roliner is a UKCA-certified medical device (certified December 2025), developed under ISO 13485 quality management. This page brings together everything a wearer, clinician, airline crew member or security officer might need - including how to travel safely with the small non-flammable CO₂ cartridge that powers the pneumatic liner.
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Everything you need to know in thirty seconds.
For passengers travelling with Roliner, and for security or airline personnel reviewing the device at screening.
Small non-flammable CO₂ cartridge
Each unit contains a single sealed CO₂ cartridge (UN1013, Division 2.2 - non-flammable, non-toxic) used to pneumatically adjust the liner fit. Water capacity well under 50 ml.
Air Travel Regulations
Permitted in carry-on and checked baggage worldwide under IATA Dangerous Goods Regulations and national equivalents (US 49 CFR 175.10, UK CAA, EASA) for compressed gas cartridges used with mobility aids.
Verification available to officers
Security staff and airline crew can confirm device registration and request the UKCA Declaration of Conformity for Roliner any time by contacting our safety team directly at enquiry@unhindr.com.
Regulatory status
Designed, tested and manufactured to medical device standards.
Roliner holds UKCA marking (December 2025) and is manufactured under a certified ISO 13485 quality management system. CE marking under EU MDR and US FDA submissions are in preparation.
UKCA marked · Dec 2025
ISO 13485 · Quality management
EN ISO 14971 · Risk management
ISO 10993 · Biocompatibility
EN ISO 22523 · External limb prostheses
MHRA registered manufacturer
Certificate numbers, Declaration of Conformity, technical file summaries and notified body details are made available to clinicians, regulators, airline operators and enterprise partners on written request. Contact enquiry@unhindr.com.
CO₂ cartridge
Why there's a compressed gas cartridge - and why it's safe.
Roliner uses a small, sealed CO₂ cartridge to inflate and adjust the pneumatic chambers inside the liner - the mechanism that lets it adapt continuously to the wearer's residual limb throughout the day.
Carbon dioxide is the same gas used in life-jacket inflators, soda siphons and bicycle tyre inflators. It is non-flammable, non-toxic, and classified as a Division 2.2 gas under UN number 1013. The cartridge screws into Roliner's control unit, which incorporates a calibrated over-pressure relief valve, and is replaced only by trained technicians.
A Roliner cartridge has a water capacity well below the 50 ml threshold that international civil aviation authorities permit for compressed gas cartridges carried with mobility aids and medical devices - the same allowance that covers self-inflating life jackets.
- Gas
- Carbon dioxide (CO₂)
- UN number
- UN 1013
- Hazard classification
- Division 2.2 - non-flammable, non-toxic
- Cartridge net gas mass
- 16 g (nominal)
- Water capacity
- < 50 ml
- Working pressure
- ≈ 60 bar @ 20 °C
- Flammable
- No
Air travel
Permitted on commercial flights worldwide.
Compressed gas cartridges used to operate medical devices and prosthetic mobility aids are expressly permitted in passenger baggage under the major international and national aviation dangerous-goods regimes, subject to airline notification.
- IATA Dangerous Goods Regulations - small non-flammable gas cartridges used to operate self-inflating or pneumatic medical and mobility devices are permitted in checked and carry-on baggage (Table 2.3.A, passenger provisions for medical devices).
- ICAO Technical Instructions - Part 8 mirrors the IATA provision, authorising compressed gas cylinders that accompany mobility and medical devices carried by passengers.
- United States - 49 CFR 175.10 (US DOT / FAA) permits non-flammable compressed gas cylinders in carry-on or checked baggage when used with a mechanical limb, mobility aid or medical device, including up to two spare cartridges with a water capacity not exceeding 50 ml each.
- United Kingdom & EU - UK CAA and EASA apply the IATA provisions through national dangerous-goods law. Passengers should notify the operating airline at least 48 hours before travel.
- TSA screening (USA) - prosthetic devices containing CO₂ cartridges may be carried through passenger checkpoints and are explicitly listed in TSA guidance on travelling with medical devices and prosthetics.
Regulations evolve and individual carriers may impose stricter rules. Passengers should always notify their airline in advance and carry a copy of the Roliner travel letter, available free of charge from enquiry@unhindr.com. The travel letter lists the device description, UN number, cartridge specification and the regulatory provisions under which it travels - in English and the language of your destination on request.
Device safety
Engineered with redundant protection at every layer.
Roliner's design dossier addresses mechanical, pneumatic, material and software risks through the ISO 14971 risk management process. Key safety features include:
Overpressure protection
A calibrated mechanical relief valve limits chamber pressure to a safe working range. The control unit the cartridge screws into is sealed and pressure-rated well beyond the maximum cartridge output.
Biocompatible materials
All skin-contacting surfaces are tested to ISO 10993 for cytotoxicity, sensitisation and irritation. Silicones, textiles and adhesives are medical-grade and traceable by lot.
Continuous monitoring & fail-safe
Integrated pressure and contact sensors continuously monitor chamber state. On loss of power or any fault, the system fails to a neutral, de-pressurised state - the liner cannot inflate uncontrolled.
For passengers
Travelling with your Roliner.
Three simple steps cover almost every journey.
Before you fly
Request your Roliner travel letter at least 48 hours in advance. Notify your airline that you'll be travelling with a prosthetic medical device containing a small non-flammable compressed gas cartridge - this is a standard procedure.
At the airport
Present your travel letter at check-in and, if asked, at security screening. The letter lists the device description, UN number, cartridge specification and the exact regulatory provisions under which it travels.
In the cabin
Keep Roliner stowed in the overhead locker or under the seat in front of you. The device is safe to wear through airport scanners and during flight; cabin-pressure changes do not affect the sealed cartridge.
For airport security & airline crew
Verify this device in under a minute.
Our safety team can confirm UKCA registration, provide the Declaration of Conformity, and authenticate travel letters 24 hours a day. If you've stopped a passenger carrying a Roliner and need to confirm device status, contact us - we'll respond immediately.
Vigilance
Reporting a safety concern.
If you experience or observe any issue with a Roliner device - whether you're the wearer, a clinician, a partner or a bystander - please tell us straight away so we can investigate and take action under our ISO 13485 post-market surveillance procedure.
- Email enquiry@unhindr.com with subject line "Safety concern - Roliner".
- Include the device serial number (found on the underside of the control unit) if known.
- Describe the event, any injury, and the date and location.
- We commit to acknowledging every report within one business day and providing a preliminary response within five business days.
- Serious incidents are reported to the MHRA under the UK Medical Devices Regulations 2002 vigilance system, in line with our post-market obligations.