Identity
- Trade Name
- Slimax-C Plus EUDAMEDFDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Canaview V2 Intra Oral Camera EUDAMEDSlimax-C Plus,Pink,Cordless, Display Panel, Built-in Radiometer FDA UDI
- Model / Reference
- EV2060 EUDAMEDSM1003P-PI EUDAMEDFDA UDI
- Description
- Slimax-C Plus,Pink,Cordless, Display Panel, Built-in Radiometer FDA UDI
Identifiers
- Catalog Number
- Slimax-C Plus FDA UDI
- Primary DI / UDI-DI
- 00990010301962 EUDAMEDFDA UDI
- Basic UDI-DI
- 9900103BeyesA7 EUDAMED
- Direct Marketing DI
- 00990010301962 EUDAMED
- 510(k) Number
- K080025 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Slimax-C Plus by Beyes Dental Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9900103BeyesA7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beyes Dental Inc
- EUDAMED SRN
- CA-MF-000001491
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7da277b0-92ac-405c-b426-d7d469ba957a 61 fields · synced May 31, 2026
- FDA UDI 7e0429b2-8dc2-4238-955a-112c017c3dbc 35 fields · synced May 30, 2026