Identity
- Trade Name
- Pentacam EUDAMEDFDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- Pentacam EUDAMEDThe Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye. FDA UDI
- Model / Reference
- 70700 EUDAMEDFDA UDI
- Description
- The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584000019 EUDAMEDFDA UDI
- Basic UDI-DI
- 40495846BL EUDAMED
- 510(k) Number
- K030719 FDA UDI
- FDA Product Code
- MXK FDA UDI
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 10.5 Kilogram FDA UDIHeight — 535 Millimeter FDA UDIDepth — 360 Millimeter FDA UDIWidth — 280 Millimeter FDA UDI
Pentacam by OCULUS Optikgeräte GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 40495846BL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED 10e6a37a-d1dc-4207-8854-509a696d6829 61 fields · synced Jun 9, 2026
- FDA UDI 287d4203-6f29-4cc5-9007-7157e65177f8 36 fields · synced May 30, 2026