SeeLuma

FDA UDI

Class I (US FDA UDI)

by Munich Surgical Imaging GmbH

Identity

Trade Name: SeeLuma FDA UDI
Generic Name: Ophthalmic surgical microscope FDA UDI
Device Name: The ophthalmic microscope is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries. FDA UDI
Model / Reference: V10760-01 FDA UDI
Description: The ophthalmic microscope is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries. FDA UDI

Identifiers

Primary DI / UDI-DI: 04064434000117 FDA UDI
FDA Product Code: HRM FDA UDI
GMDN Term: Ophthalmic surgical microscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 1830 Millimeter FDA UDI
Depth — 840 Millimeter FDA UDI
Height — 1965 Millimeter FDA UDI

Category: Ophthalmic surgical microscope

SeeLuma by Munich Surgical Imaging GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Munich Surgical Imaging GmbH

Sources (1)

FDA UDI 877018e9-5396-43cf-bae9-aa674efdbb0c 35 fields · synced May 30, 2026