Identity
- Trade Name
- Chromophare F300 FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Berchtold Examination Light ? Ceiling Mounted FDA UDI
- Model / Reference
- CE2853075 FDA UDI
- Description
- Berchtold Examination Light ? Ceiling Mounted FDA UDI
Identifiers
- Catalog Number
- CE 2853075 FDA UDI
- Primary DI / UDI-DI
- 07613327296266 FDA UDI
- FDA Product Code
- KZF FDA UDI
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Fixed examination/treatment room light
Chromophare F300 by Berchtold Holding GmbH — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K935832 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K965130 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K922836 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K944855 | Class I | Active |
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Manufacturer
- Manufacturer
- Berchtold Holding GmbH
Sources (2)
- FDA UDI a03fc6bb-2255-4c55-a5b2-8d926dc85d9b 59 fields · synced Jun 19, 2026
- FDA 510(k) K935832 1 fields · synced May 25, 2026