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Sign in to claim this brandOrthocell Ltd
Australia·AU-MF-000018345
Last updated September 18, 2026
About
Proprietary SMRT™ manufacturing of Remplir™ collagen nerve wrap & Striate+™ collagen membranes. Cell therapies OrthoACI™ for cartilage & OrthoATI™ for tendon injuries.
From the manufacturer's own website. Source
What Orthocell Ltd makes
Orthocell Ltd produces collagen-based nerve wraps under the Remplir brand in multiple sizes, designed for nerve protection and repair. It also manufactures Striate+ collagen membranes, intended for surgical applications requiring tissue integration. The company’s portfolio includes OrthoACI and OrthoATI cell therapies, which are intended for cartilage and tendon injury treatments, respectively.
The company’s devices are classified as Class II and Class III under regulatory frameworks, with products listed in the EU’s eudamed registry and the FDA’s 510(k) database. Orthocell Ltd is based in Australia and operates within these international regulatory systems for medical device authorisation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Australia
- Address
- Building 191, South Street, Murdoch University, Murdoch , Australia
- Website
- www.orthocell.com
- linkedin.com/company/orthocell-ltd
- facebook.com/Orthocell
- [email protected]
- Phone
- +61 08 9360 2888
- PRRC Contact
- Alison Carleton
- EUDAMED SRN
- AU-MF-000018345
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | K243889 | FDA 510(k) | Class II | Active |
| Striate+ | OCG-152, OCG-203, OCG-304, OCG-405, OCG-050, OCG-070 | EUDAMED | Class III | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Orthocell Limited US