SDI 4e electrically

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: SDI 4e electrically FDA UDI
Generic Name: Ophthalmic surgical microscope FDA UDI
Device Name: SDI 4e electrically FDA UDI
Model / Reference: 54300 FDA UDI
Description: SDI 4e electrically FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584008039 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

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

Category: Ophthalmic surgical microscope

SDI 4e electrically by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical microscope.

MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
OPMI Lumera 700 — Carl Zeiss Meditec AG · Class I
LuxOR — Alcon Laboratories, Inc. · Class I
LuxOR Revalia — Alcon Laboratories, Inc. · Class I
MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
LuxOR — Alcon Laboratories, Inc. · Class I
INAMI — INAMI & CO., LTD. · Class I
SeeLuma Digital Binoculars Upgrade Kit — Munich Surgical Imaging GmbH · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI e6787201-c4c3-473c-b524-13771e962e1c 34 fields · synced May 30, 2026