Identity
- Trade Name
- Ergoline SR Super Power FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- UV - Tanning lamp, Accession # 122 0531-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy Weymouth, MA 02189, Phone: +1 781 331 0949, Email: [email protected] <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: [email protected], http://www.narva-bel.de FDA UDI
- Model / Reference
- FR71T12 100W-R FDA UDI
- Description
- UV - Tanning lamp, Accession # 122 0531-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy Weymouth, MA 02189, Phone: +1 781 331 0949, Email: [email protected] <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: [email protected], http://www.narva-bel.de FDA UDI
Identifiers
- Catalog Number
- 901935140 FDA UDI
- Primary DI / UDI-DI
- 04014501003480 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ergoline SR Super Power by NARVA Lichtquellen GmbH + Co KG. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- NARVA Lichtquellen GmbH + Co KG.
Sources (1)
- FDA UDI 7b99514f-290a-4454-9378-af9e5d9e2321 37 fields · synced Jun 1, 2026