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Sign in to claim this brandFOOT SCIENCE INTERNATIONAL LIMITED
New Zealand·NZ-MF-000044443
Last updated May 27, 2026
What FOOT SCIENCE INTERNATIONAL LIMITED makes
The company produces prefabricated orthotic insoles, including both antimicrobial and non-antimicrobial variants. These devices are designed to provide foot support and are intended for general use in managing foot-related conditions.
The portfolio consists of Class I medical devices, which are listed in the EU’s EUDAMED database and the FDA’s UDI system. The company is based in New Zealand.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Foot Science International Limited manufacture?
Foot Science International Limited specialises in prefabricated orthotic insoles, which are designed to provide foot support. These devices come in two primary variants: antimicrobial and non-antimicrobial. They are intended for general use in managing foot-related conditions, such as pain relief, biomechanical correction, or improved comfort.
Where is Foot Science International Limited based?
The company is headquartered in New Zealand, where its operations and product development are centred. This location influences its regulatory compliance processes, particularly for markets like the EU and the US.
Which regulatory registries list Foot Science International Limited’s devices?
The company’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices in their respective markets, helping healthcare providers and regulators verify compliance.
How are Foot Science International Limited’s devices classified under medical device regulations?
All devices produced by Foot Science International Limited fall under Class I classification. This classification applies to low-risk devices, such as prefabricated orthotic insoles, which pose minimal risk to patients when used as intended. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- New Zealand
- Address
- 26, Dakota Crescent, Christchurch, New Zealand
- Website
- fsinz.onmicrosoft.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Anne Arndt
- EUDAMED SRN
- NZ-MF-000044443
- FDA FEI Number
- —
- DUNS Number
- 590255113
Catalogue (188)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Formthotics | A-01-EwPl-Bk-M | FDA UDI | Class I | Active |
| Formthotics | E3q-01-Re-K | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-OrSpA-Cb-ME | FDA UDI | Class I | Active |
| Formthotics | 3d-01-ApSa-Bl-M | FDA UDI | Class I | Active |
| Formthotics | A-01-4mPl-Re-S | FDA UDI | Class I | Active |
| Formthotics | FM01-OrDuA-Pn-XL | FDA UDI | Class I | Active |
| Formthotics | FM01-OrShA-Re-XS | FDA UDI | Class I | Active |
| Formthotics | 3d-01-RFwSa-Gr-L | FDA UDI | Class I | Active |
| Formthotics | EFl-01-Bl-M | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-SfDmBpGg-XL | FDA UDI | Class I | Active |
| Formthotics | FM01-OrSsA-Bu-2L | FDA UDI | Class I | Active |
| Formthotics | EFl-01-Bl-XL | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | E3q-01-Bl-S | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-LpDmB-Bg-XS | FDA UDI | Class I | Active |
| Formthotics | A-01-RwSa-Bl-M | FDA UDI | Class I | Active |
| Formthotics | FM01-OrSmA-Bl-2S | FDA UDI | Class I | Active |
| Formthotics | A-01-4mPl-Re-L | FDA UDI | Class I | Active |
| Formthotics | E3q-01-Re-XS | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-OrXsB-Be-Y1 | FDA UDI | Class I | Active |
| Formthotics | E3q-01-Re-L | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-SfDmBpBg-LA | FDA UDI | Class I | Active |
| Formthotics | EFl-01-Bl-K | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | A-01-6mSa-Re-L | FDA UDI | Class I | Active |
| Formthotics | FM01-WfDmA-Gg-ME | FDA UDI | Class I | Active |
| Formthotics | FM01-OrSpA-Cb-SM | FDA UDI | Class I | Active |
| Formthotics | FM01-WfDmA-Bg-XS | FDA UDI | Class I | Active |
| Formthotics | FM01-SfDmBpBg-ME | FDA UDI | Class I | Active |
| Formthotics | FM01-OrSuA-Na-SM | FDA UDI | Class I | Active |
| Formthotics | FM01-LpDmB-Bg-LA | FDA UDI | Class I | Active |
| Formthotics | A-01-RwSa-Bl-S | FDA UDI | Class I | Active |
| Formthotics | 3d-01-TrwSa-Or-M | FDA UDI | Class I | Active |
| Formthotics | A-01-ApSa-Re-M | FDA UDI | Class I | Active |
| Formthotics | EFl-01-Re-M | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-OrXsB-Be-Y2 | FDA UDI | Class I | Active |
| Formthotics | 3d-01-ApSa-Bl-L | FDA UDI | Class I | Active |
| Formthotics | EFl-01-Bl-S | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-OrXsB-Be-Y3 | FDA UDI | Class I | Active |
| Formthotics | FM01-OrSsA-Bu-SM | FDA UDI | Class I | Active |
| Formthotics | A-01-RwSa-Bk-S | FDA UDI | Class I | Active |
| Formthotics | FM01-WfDmA-Bg-2L | FDA UDI | Class I | Active |
| Formthotics | A-01-6mSa-Re-S | FDA UDI | Class I | Active |
| Formthotics | FM01-OrXsA-Be-LA | FDA UDI | Class I | Active |
| Formthotics | FM01-OrXsA-Be-2S | FDA UDI | Class I | Active |
| Formthotics | FM01-WfDmA-Bg-XL | FDA UDI | Class I | Active |
| Formthotics | E3q-01-Re-XL | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | EFl-01-Re-K | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | E3q-01-Bl-M | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | EFl-01-Bl-L | EUDAMEDFDA UDI | Class I | Active |
| Formthotics | FM01-SfDmApBg-2L | FDA UDI | Class I | Active |
| Formthotics | E3q-01-Bl-XL | EUDAMEDFDA UDI | Class I | Active |
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