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Rovers® Viba-Brush RT
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 380320331510(k) K933870
Identity
- Trade Name
- Rovers® Viba-Brush RT EUDAMED
- Device Name
- Rovers® Viba-Brush EUDAMED
- Model / Reference
- 380320331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719189246254 EUDAMED
- Basic UDI-DI
- 87191892463803203315K EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rovers® Viba-Brush RT by Rovers Medical Devices B.V. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933870 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 87191892463803203315K | Class I | Active |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
- EUDAMED SRN
- NL-MF-000001553
- FDA Applicant
- Rovers B.V.
Sources (2)
- EUDAMED a4936a13-819c-4814-ad3d-f223d0c99365 85 fields · synced Jun 18, 2026
- FDA 510(k) K933870 1 fields · synced May 18, 2026