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Venus Plus
EUDAMEDFDA UDIClass I (EU MDR)
Ref 96601080Model Operating light
by CEFLA s.c.
Identity
- Trade Name
- VENUS PLUS EUDAMEDCEFLA FDA UDI
- Generic Name
- Reflective dental room light FDA UDI
- Device Name
- The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment. FDA UDI
- Model / Reference
- Operating light EUDAMED96601080 EUDAMEDVENUS PLUS FDA UDI
- Description
- The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment. FDA UDI
Identifiers
- Catalog Number
- 96601080 FDA UDI
- Primary DI / UDI-DI
- 08033837933038 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793TROPLAMP1001RQ EUDAMED
- Direct Marketing DI
- 08033837933038 EUDAMED
- FDA Product Code
- EAZ FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Reflective dental room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4630 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
Venus Plus by CEFLA s.c. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 803383793TROPLAMP1001RQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED 29f0c065-fb20-4a9a-b687-3d962cdb14d0 61 fields · synced Sep 18, 2026
- FDA UDI 142b200e-a559-489d-aae8-fd1145b5fd4b 36 fields · synced May 30, 2026