← Back to catalogue
moorFLPI-2
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref moorFLPI-2510(k) K122943
Identity
- Trade Name
- moorFLPI-2 EUDAMEDMoor Instruments Ltd FDA UDI
- Generic Name
- Cutaneous microcirculation laser Doppler imaging device FDA UDI
- Device Name
- moorFLPI-2 and PC Software EUDAMEDmoorFLPI2 - Full-Field Laser Perfusion Imager FDA UDI
- Model / Reference
- moorFLPI-2 EUDAMEDmoorFLPI2 FDA UDI
- Description
- moorFLPI2 - Full-Field Laser Perfusion Imager FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060484490041 EUDAMEDFDA UDI
- Basic UDI-DI
- B-15060484490041 EUDAMED
- 510(k) Number
- FDA Product Code
- DPT FDA 510(k)FDA UDI
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
- GMDN Term
- Cutaneous microcirculation laser Doppler imaging device FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2120 FDA 510(k)
- Regulation Number
- 870.2120 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
moorFLPI-2 by Moor Instruments Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: moorFLPI-2 Research Software
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122943 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-15060484490041 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Moor Instruments Ltd
- EUDAMED SRN
- UK-MF-000042552
- Authorised Representative
- Moor Instruments GmbH DE-AR-000041822
Sources (4)
- EUDAMED 433d0515-97cb-4561-b008-1ed4465304c2 61 fields · synced Aug 4, 2026
- FDA 510(k) K122943 24 fields · synced May 18, 2026
- FDA UDI 8486bcfa-c98e-4507-a6b7-bde3246fce5d 36 fields · synced May 26, 2026
- EUDAMED 816b8c2c-5ca9-42c7-b603-9abdf705f7c2 61 fields · synced Aug 4, 2026