Drive unit for BIOM c

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: Drive unit for BIOM c FDA UDI
Generic Name: Ophthalmic surgical microscope FDA UDI
Device Name: Drive unit for BIOM c FDA UDI
Model / Reference: 54405 FDA UDI
Description: Drive unit for BIOM c FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584008237 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical microscope

Drive unit for BIOM c by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — 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: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI 594c8164-f7b9-4e0a-9a7c-158eac3acf5d 34 fields · synced Jun 1, 2026