RZ Medizintechnik GmbH

FDA UDI

Class II (US FDA UDI)

by RZ-Medizintechnik GmbH

Identity

Trade Name: RZ Medizintechnik GmbH FDA UDI
Generic Name: General-purpose light source FDA UDI
Device Name: LUMEN LED 1 High Intensity Light Source 180W FDA UDI
Model / Reference: 300-900-180 FDA UDI
Description: LUMEN LED 1 High Intensity Light Source 180W FDA UDI

Identifiers

Catalog Number: 300-900-180 FDA UDI
Primary DI / UDI-DI: 04049197465007 FDA UDI
FDA Product Code: FCW FDA UDI
GMDN Term: General-purpose light source FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General-purpose light source

RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: RZ-Medizintechnik GmbH

Sources (1)

FDA UDI 7086f960-a61e-4972-9666-3f9d640a2510 35 fields · synced May 30, 2026