Identity
- Trade Name
- Heraeus Noblelight America LLC FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- UV - Tanning lamp, Accession # 1620 384-000 <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 MAT 1000 AF FDA UDI
- Description
- UV - Tanning lamp, Accession # 1620 384-000 <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
- 8004 1312 FDA UDI
- Primary DI / UDI-DI
- 04054657500563 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
Yes
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
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 a9c497e9-5c14-4485-8e10-c924e5aba525 37 fields · synced Jun 6, 2026