Identity
- Trade Name
- Fischer FDA UDI
- Generic Name
- Hyperhidrosis iontophoresis system FDA UDI
- Device Name
- Fischer Model MD-2 Galvanic Unit FDA UDI
- Model / Reference
- MD-2 Galvanic Unit FDA UDI
- Description
- Fischer Model MD-2 Galvanic Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- M730MD20 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Hyperhidrosis iontophoresis system 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hyperhidrosis iontophoresis system
Fischer by A.R. Hinkel Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Drionic TM — General Medical 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
- A.R. Hinkel Co., Inc.
Sources (1)
- FDA UDI 7e4f4722-b78e-4b39-a4a6-3521c5d345c3 34 fields · synced Jun 6, 2026