Home / Evidence & Regulatory
Everything a hospital procurement team, a notified body or a distribution partner asks for, in one place.
Registration or listing with a regulator is not approval, clearance or endorsement. We say "US FDA listed" because that is what we hold. CE marking is by declaration of conformity as Class I devices.
We list what we hold rather than publishing the certificates themselves. Any certificate, declaration of conformity or registration document is sent by email on request, the same way the instructions for use are.
| Market | Regulatory basis | Commercial status |
|---|---|---|
| India | CDSCO · manufacturing site, Savli, Gujarat | Direct and distribution |
| United States | US FDA listed · OrthoHeal Inc, Texas | Partner distribution |
| European Union | CE (MDR) · OrthoHeal GmbH, Hamburg | Active |
| Saudi Arabia | SFDA registered | Active |
| United Arab Emirates | MOHAP registered | Active |
| Australia | TGA — ARTG listed | Registered |
| South Korea | NIDS registered | Exclusive partner |
| Taiwan | TFDA registered | Active |
| Mexico and Latin America | Local registration via partners | Active — Mexico, Venezuela, Ecuador, Costa Rica |
| Vietnam | DMEHW registered | Registered |
| Rest of world | Registration support available | Territories open |
Independent and post-market studies of light-cured polymer immobilisation, in indexed journals.
Reyes Martínez O, Stavitz J, Olmeda-Mercado K, Negrón-Rodríguez V, Porcelli R
108 patients. Anatomic or near-anatomic alignment at device removal in 103 of 104 fractures (99.1%); radiographic union or progression to union where follow-up imaging was available. Two mild skin reactions, twelve device breakages, no severe complications.
Bali T, Garg B, Raghavendran R
137 participants, five Indian sites, distal radius fractures. Radiographic healing in 100% of participants; adverse events minimal — wrist stiffness 20.3%, distal oedema 17.5%, skin infection 1.5%.
Stavitz J, Porcelli R, Vachhani A
Synthesises 87 studies on the physical, psychological, social and economic burden of plaster and fiberglass casting, and positions light-cured polymer mesh systems as patient-centred alternatives that maintain stability while reducing that burden.
Distal radius, metacarpal, scaphoid, ankle and paediatric cases from India, the USA, Mexico, Venezuela and Guatemala — written up as one-page case studies with images and follow-up, shared on request.
GBD 2019 Fracture Collaborators
178 million new fractures a year worldwide; lower-leg fractures the most common and most burdensome.
The generation-by-generation comparison on this site, written up with sources. on request
Posters and presentations given at congresses since 2019. on request
Tell us your name and email and we send the document straight to your inbox. Certificates, declarations of conformity and test summaries are supplied on request to hospitals, procurement teams, notified bodies and distribution partners.
Current EU MDR editions. The IFU is the authoritative document for indications, contraindications, application and removal.
Certificates, declarations of conformity, test summaries, translated IFUs, price lists or anything not in the library above. We reply from the regional office that covers you.
FlexiOH is supplied non-sterile and is applied over intact or dressed skin as directed by the clinician. Confirm against the IFU for the specific variant.
Application where the immobilizer would contact breached skin. Severe oedema requires immediate clinical review. See the IFU for the full list.
Yes. Each immobilizer is fitted and cured to one patient's limb and cannot be reshaped or reused.
A RizyCure Corded curing light — Class I, Type B, 110–240 V mains. Plan light-device count against daily cast volume; maximum continuous run is about 10 minutes.
Cut away with bone-cutting forceps; no saw. The immobilizer is recyclable. Follow local clinical-waste policy.
Email care@orthoheal.com. Complaints are handled under the ISO 13485 quality system.
Tell us which document, certificate or dossier you need and for which market.