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VOX Implants, 1.0 cc syringe fill, 3.0 cc polycarbonate syringe
EUDAMEDClass IIb (EU MDR)
Ref VOX-1.0Model VOX – 1.0 cc syringe
Identity
- Trade Name
- VOX Implants, 1.0 cc syringe fill, 3.0 cc polycarbonate syringe EUDAMED
- Device Name
- VOX Implants, 1.0 cc syringe fill, 3.0 cc polycarbonate syringe EUDAMED
- Model / Reference
- VOX – 1.0 cc syringe EUDAMEDVOX-1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717591240204 EUDAMED
- Basic UDI-DI
- B-08717591240204 EUDAMED
- EMDN Code
- P900403 NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VOX Implants, 1.0 cc syringe fill, 3.0 cc polycarbonate syringe by Uroplasty, LLC — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717591240204 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Uroplasty, LLC
- EUDAMED SRN
- US-MF-000041660
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (1)
- EUDAMED a708afae-9955-476d-b3c8-f082f329ed2e 61 fields · synced Jul 13, 2026