FDA Registration
Active
🇺🇸 United States
Carestream Health, Inc.
Reg #: 1317267
·
FEI: 1317267
·
Expires 2026
Products
1
Proprietary Names
19
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Carestream Health, Inc.
- Registration Number
- 1317267
- FEI Number
- 1317267
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1669 Lake Avenue
- City
- Rochester
- State
- NY
- ZIP
- 14652
- Country
- US
Owner / Operator
- Firm Name
- Carestream Health, Inc.
- Operator Number
- 9097221
- Address
- 150 Verona Street
- City
- Rochester
- State
- NY
- Postal Code
- 14608
- Country
- US
- Correspondent
- Alyssa J Haig
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2006-06-01 |
Proprietary Names
T-MAT G/RA
X-OMAT 2 Dental Duplicating
DRYVIEW DVB+ Laser Imaging Film
DRYVIEW DVM+ Mammography Laser Imaging Film
Ultra-speed
DRYVIEW DVB+ Premium Laser Imaging Film
DRYVIEW DVE Laser Imaging Film
INSIGHT
AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV
AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV
GBX Fixer and Replenisher
GBX Developer and Replenisher
AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV
AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV
Rapid Access Twin Pack
READYPRO Twin Pack
TRIMAX TXM Laser Imaging Film
DRYVIEW DVM Mammography Laser Imaging Film
SD-SM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device