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Heraeus Noblelight America LLC

FDA UDI

Class II (US FDA UDI)

by G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

Identity

Trade Name
Heraeus Noblelight America LLC FDA UDI
Generic Name
Ultraviolet tanning device FDA UDI
Device Name
UV - Tanning lamp FDA UDI
Model / Reference
Strahler HNI MAT 1000 F FDA UDI
Description
UV - Tanning lamp FDA UDI

Identifiers

Catalog Number
8001 0768 FDA UDI
Primary DI / UDI-DI
04054657500570 FDA UDI
510(k) Number
K151674 FDA UDI
FDA Product Code
LEJ FDA UDI
GMDN Term
Ultraviolet tanning device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4635 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Heraeus Noblelight America LLC by G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K151674 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

Sources (1)

  • FDA UDI b1e5091b-62e7-4b1a-bc3b-d6c77cd48291 37 fields · synced May 30, 2026