Identity
- Trade Name
- EndyMed PRO MAX, Contour MAX Handpiece FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite. FDA UDI
- Model / Reference
- Contour MAX Handpiece FDA UDI
- Description
- The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00467-00 FDA UDI
- Primary DI / UDI-DI
- 07290016814477 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
EndyMed PRO MAX, Contour MAX Handpiece by Endymed Medical Ltd — 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
- Endymed Medical Ltd
Sources (1)
- FDA UDI bb56dcfa-3831-4f26-9b5f-e4902b97cff4 36 fields · synced Jun 8, 2026