← Back to catalogue
Microperimeter MP-3
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref 16202-0040,16202-0S40Model MP-3510(k) K152729510(k) K190198
Identity
- Trade Name
- Microperimeter MP-3 EUDAMEDMICROPERIMETER FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. FDA UDI
- Model / Reference
- MP-3 EUDAMEDFDA UDI16202-0040,16202-0S40 EUDAMED
- Description
- The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101339 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669215GD EUDAMED
- 510(k) Number
- K190198 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)FDA UDIHPT FDA UDI
- EMDN Code
- Z1212012080,Z12120199 EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)FDA UDI886.1605 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Ophthalmic 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
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
No
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
Microperimeter MP-3 by Nidek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190198 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K152729 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4987669215GD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- FDA Applicant
- Nidek Co., Ltd.
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (4)
- EUDAMED 7b85d206-36bb-4675-9803-2fc2d5a52b8e 85 fields · synced Jul 27, 2026
- FDA 510(k) K190198 24 fields · synced May 18, 2026
- FDA UDI e03bf6e8-4072-4371-a393-04c1f3c82c14 34 fields · synced May 30, 2026
- EUDAMED 7b85d206-36bb-4675-9803-2fc2d5a52b8e-1 61 fields · synced Jul 27, 2026