Identity
- Trade Name
- Chromophare FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Surgical Light System ? Ceiling Mounted FDA UDI
- Model / Reference
- CH00000001 FDA UDI
- Description
- Surgical Light System ? Ceiling Mounted FDA UDI
Identifiers
- Catalog Number
- CH00000001 FDA UDI
- Primary DI / UDI-DI
- 07613327296167 FDA UDI
- FDA Product Code
- KZF FDA UDIFSY FDA UDI
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6320 FDA UDI878.4580 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: Operating room light systemFixed examination/treatment room light
Chromophare by Berchtold Holding GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Berchtold Holding GmbH
Sources (1)
- FDA UDI 244b08e6-4062-481b-ac5f-708900df371d 35 fields · synced May 30, 2026