SPECTRALIS, HEP Image Capture Module SW V1.2.4
by Heidelberg Engineering GmbH
SPECTRALIS, HEP Image Capture Module SW V1.2.4 is a Class I device made by Heidelberg Engineering GmbH, listed in FDA GUDID since 11 Jul 2018 (UDI-DI 04059237000396), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04059237000396 | Date11 Jul 2018 | StatusListed |
Official records
- AccessGUDID record 04059237000396
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Spectralis, Hep
- Generic name
- Perimeter, automatic
- Model / reference
- Image Capture Module SW V1.2.4
- Primary DI / UDI-DI
- 04059237000396
- FDA product code
- HOO, OBO, MYC
- GMDN term
- Perimeter, automatic
- Device class
- Class I
- Regulation number
- 886.1605, 886.1570
- GUDID distribution status
- In Commercial Distribution
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