Identity
- Trade Name
- AC Cream - Conductive Cream EUDAMEDAC Cream - Conductive Paste FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Gel and Creams EUDAMED
- Model / Reference
- ACCREAM250V-3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 18054655023661 EUDAMEDFDA UDI
- Basic UDI-DI
- 8054655000012XV EUDAMED
- FDA Product Code
- GYB FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1275 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
AC Cream - Conductive Cream by Spes Medica S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8054655000012XV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spes Medica S.p.A.
- EUDAMED SRN
- IT-MF-000008858
Sources (2)
- EUDAMED 250ce974-73fe-414a-877f-4c8ac7da18bf 61 fields · synced Jul 27, 2026
- FDA UDI 30370819-8452-4884-9df5-ca726fd3aafc 32 fields · synced May 30, 2026