Identity
- Trade Name
- MATTIOLI FDA UDI
- Generic Name
- Drug-delivery iontophoresis system, reusable FDA UDI
- Device Name
- Pulsed Iontophoresis Device with handpiece FDA UDI
- Model / Reference
- DEP SYSTEM PRO FDA UDI
- Description
- Pulsed Iontophoresis Device with handpiece FDA UDI
Identifiers
- Catalog Number
- 33320060/B FDA UDI
- Primary DI / UDI-DI
- 08054383090006 FDA UDI
- 510(k) Number
- K042590 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Drug-delivery iontophoresis system, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 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
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
Category: Drug-delivery iontophoresis system, reusable
Mattioli by Mattioli Engineering Italia Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mattioli Engineering Italia Spa
Sources (1)
- FDA UDI 78469251-ff2d-4091-b6bc-ae219c3b22b2 35 fields · synced May 30, 2026