Identity
- Trade Name
- NEWA PLUS Kit FDA UDI
- Generic Name
- Home-use radio-frequency skin contouring unit FDA UDI
- Device Name
- The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV. FDA UDI
- Model / Reference
- Plus, Lavender FDA UDI
- Description
- The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00438-00 FDA UDI
- Primary DI / UDI-DI
- 07290014660014 FDA UDI
- FDA Product Code
- PAY FDA UDI
- GMDN Term
- Home-use radio-frequency skin contouring unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home-use radio-frequency skin contouring unit
NEWA PLUS Kit by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
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
- Endymed Medical Ltd
Sources (1)
- FDA UDI 0423140f-b464-4765-8099-ef8bc4e17b88 35 fields · synced May 30, 2026