Identity
- Trade Name
- Heraeus Noblelight America LLC FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- UV - Tanning lamp, Accession # 0631196-001 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, [email protected], http://www.original-hanau.com <CR> Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, [email protected], http://www.narva-gle.com FDA UDI
- Model / Reference
- Strahler HNI MAT 1000 F FDA UDI
- Description
- UV - Tanning lamp, Accession # 0631196-001 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, [email protected], http://www.original-hanau.com <CR> Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, [email protected], http://www.narva-gle.com FDA UDI
Identifiers
- Catalog Number
- 8001 0768 FDA UDI
- Primary DI / UDI-DI
- 14054657500089 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
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet tanning device
Heraeus Noblelight America LLC by G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH — Class II — 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 II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI eb8860ce-990e-42c6-83b0-dd7df767b839 35 fields · synced Jun 8, 2026