Identity
- Trade Name
- endyMed PRO MAX, Intensif MAX Handpiece FDA UDI
- Generic Name
- Cosmetic micro-needling electronic handpiece, professional FDA UDI
- Device Name
- The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis FDA UDI
- Model / Reference
- Intensif MAX Handpiece FDA UDI
- Description
- The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis FDA UDI
Identifiers
- Catalog Number
- ND_PRD00462-00 FDA UDI
- Primary DI / UDI-DI
- 07290016814415 FDA UDI
- 510(k) Number
- K130501 FDA UDI
- FDA Product Code
- GEI FDA UDIOUH FDA UDI
- GMDN Term
- Cosmetic micro-needling electronic handpiece, professional 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, Intensif MAX Handpiece by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 e1cb31ee-eb5a-49ed-894e-fa7cf436053f 37 fields · synced May 30, 2026