WFE lens for BIOM 5

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: WFE lens for BIOM 5 FDA UDI
Generic Name: Ophthalmic surgical microscope FDA UDI
Device Name: WFE lens for BIOM 5 FDA UDI
Model / Reference: 53602 FDA UDI
Description: WFE lens for BIOM 5 FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584007735 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic surgical microscope

WFE lens for BIOM 5 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 c3a2a779-1c06-4f85-b493-3cf810b999f0 34 fields · synced Jun 1, 2026