Manufacturer
BioSculptor
United StatesLegal entities : BioSculptor Corporation
Markets : Belgium · Germany · United States
Approvals : EU – class I · United States (FDA) – 510(k) : 1 · class I, II · latest in 2009 · see on the FDA website
EU representative : Eurolink Europe Compliance Limited (Ireland)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Orthoses, upper extremity - other | Y060699 | I MDR | EUDAMED record Report an error | |
| Hand orthoses | Y060606 | I MDR | EUDAMED record Report an error | |
| Lower extremity orthoses - other | Y061299 | I MDR | EUDAMED record Report an error | |
| Passive ankle-foot orthoses | Y06120601 | I MDR | EUDAMED record Report an error | |
| Wrist-hand orthoses | Y060612 | I MDR | EUDAMED record Report an error |
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