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VOCO Profluorid Varnish + BioMin
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 2266Ref 2273Ref 2267Ref 2274Ref 2277Ref 2276Ref 2272Ref 2269Ref 2271Ref 2279Ref 2270
by VOCO GmbH
Identity
- Trade Name
- VOCO Profluorid Varnish + BioMin EUDAMED
- Device Name
- VOCO Profluorid Varnish + BioMin EUDAMED
- Model / Reference
- 2266 EUDAMED2273 EUDAMED2267 EUDAMED2274 EUDAMED2277 EUDAMED2276 EUDAMED2272 EUDAMED2269 EUDAMED2271 EUDAMED2279 EUDAMED2270 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22122661 EUDAMEDE22122731 EUDAMEDE22122671 EUDAMEDE22122741 EUDAMEDE22122771 EUDAMEDE22122761 EUDAMEDE22122721 EUDAMEDE22122691 EUDAMEDE22122711 EUDAMEDE22122791 EUDAMEDE22122701 EUDAMED
- Basic UDI-DI
- ++E22100160100000008Z EUDAMED
- EMDN Code
- Q019008 DENTINAL DESENSITISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
VOCO Profluorid Varnish + BioMin by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
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 | K080814 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K083036 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252073 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E22100160100000008Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (12)
- EUDAMED a9551b30-ea40-4fe6-af03-af226d224235 61 fields · synced Sep 18, 2026
- EUDAMED f4930e33-82f9-4948-87b4-77c9ce14bd9d 61 fields · synced Jul 9, 2026
- EUDAMED b653d667-4d99-4baf-83c3-038127c853cd 61 fields · synced Jul 11, 2026
- EUDAMED d0f0ab6d-6608-45c3-9e24-9795fd5139bf 61 fields · synced Jul 15, 2026
- EUDAMED 1e45109d-5564-4a99-a25f-d421a9fc65b1 61 fields · synced Jul 17, 2026
- EUDAMED 00b27219-f1b6-4d5c-af7a-9cb8f95efe93 61 fields · synced Jul 19, 2026
- EUDAMED ce47db20-cfcc-47c3-ad66-a2c5dd9e1c84 61 fields · synced Jul 21, 2026
- EUDAMED e05a0b63-4756-41a0-b8fa-6f94b9270aaf 61 fields · synced Jul 26, 2026
- EUDAMED f502f3f0-2e2c-4c30-a252-653ceedaa437 61 fields · synced Jul 27, 2026
- EUDAMED 2026ac71-2314-4dca-a261-05558d94ad67 61 fields · synced Jul 30, 2026
- EUDAMED 71510869-8479-4b53-ac24-3951302c54fc 61 fields · synced Sep 18, 2026
- FDA 510(k) K080814 1 fields · synced May 18, 2026