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Specular Microscope Cem-530

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref B01E008Model CEM-530

by NIDEK.CO.Ltd.,

Identity

Trade Name
SPECULAR MICROSCOPE CEM-530 EUDAMED
SPECULAR MICROSCOPE FDA UDI
Generic Name
Optical pachymeter FDA UDI
Device Name
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. FDA UDI
Model / Reference
CEM-530 EUDAMEDFDA UDI
B01E008 EUDAMED
Description
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669100530 EUDAMEDFDA UDI
Basic UDI-DI
4987669211G5 EUDAMED
FDA Product Code
NQE FDA UDI
EMDN Code
Z12120116,Z12120199 EUDAMED
GMDN Term
Optical pachymeter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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

Specular Microscope Cem-530 by Nidek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
NIDEK.CO.Ltd.,
EUDAMED SRN
JP-MF-000040151
Authorised Representative
NIDEK SA FR-AR-000000341

Sources (3)

  • EUDAMED bb06654b-dd92-4766-8913-c19f47d04892 61 fields · synced Jul 9, 2026
  • FDA UDI a25178a7-e538-460d-85bf-7a9ac62f5b91 34 fields · synced May 30, 2026
  • FDA 510(k) K130565 1 fields · synced May 18, 2026