BIOM 5ml long version mechanically focused

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: BIOM 5ml long version mechanically focused FDA UDI
Generic Name: Ophthalmic surgical microscope FDA UDI
Device Name: BIOM 5ml long version mechanically focused FDA UDI
Model / Reference: 55463 FDA UDI
Description: BIOM 5ml long version mechanically focused FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584009081 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

BIOM 5ml long version mechanically focused by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID

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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 60acce87-6def-4ff5-95d9-55d8b499506b 34 fields · synced May 29, 2026