Identity
- Trade Name
- ActivaDose II FDA UDI
- Generic Name
- Drug-delivery iontophoresis system generator FDA UDI
- Device Name
- Iontophoresis Delivery Unit FDA UDI
- Model / Reference
- 001-48 FDA UDI
- Description
- Iontophoresis Delivery Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859975005011 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Drug-delivery iontophoresis system generator 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
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
Category: Drug-delivery iontophoresis system generator
ActivaDose II by Activatek Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drug-delivery iontophoresis system generator.
- Iontophor®-II — WR Medical Electronics Co. · 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
- Activatek Inc.
Sources (1)
- FDA UDI 26a16d73-2298-41c6-8c6b-ef5e8e11909f 33 fields · synced May 31, 2026