← Back to catalogue
Promap Lite
EUDAMEDFDA UDIClass I (EU MDR)
Ref KSOF-2602-LiModel PROMAP LITE
by Koelis
Identity
- Trade Name
- PROMAP LITE EUDAMEDPROMAP LITE – 3D PROSTATE SUITE FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- PROMAP LITE EUDAMEDProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure. FDA UDI
- Model / Reference
- PROMAP LITE EUDAMEDKSOF-2602-Li EUDAMEDKSOF-2602 FDA UDI
- Description
- ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000714 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03665134000714 EUDAMED
- 510(k) Number
- K170521 FDA UDI
- FDA Product Code
- LLZ FDA UDIITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040192 ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Promap Lite by Koelis — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03665134000714 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (2)
- EUDAMED 589e3667-0ebc-4030-88f3-fb300a0aae16 61 fields · synced Jun 18, 2026
- FDA UDI 1e2c0ba0-bafa-4a3e-9083-aba96578ca63 35 fields · synced May 30, 2026