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Alpha-Stim
EUDAMEDFDA UDIClass I (EU MDR)
Ref SL50Model Alpha-Stim Conductive Solution
Identity
- Trade Name
- Alpha-Stim EUDAMEDFDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Alpha-Stim Conductive Solution EUDAMEDConducting solution FDA UDI
- Model / Reference
- Alpha-Stim Conductive Solution EUDAMEDSL50 EUDAMED18-50-155614 FDA UDI
- Description
- Conducting solution FDA UDI
Identifiers
- Catalog Number
- SL50 FDA UDI
- Primary DI / UDI-DI
- 10855683006880 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300618000JF EUDAMED
- Unit of Use DI
- 00855683006883 EUDAMED
- 510(k) Number
- K780973 FDA UDI
- FDA Product Code
- GYB FDA UDI
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alpha-Stim by Parker Laboratories, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300618000JF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED b64a0e2e-a3d4-453a-9af1-37c4e06782a3 61 fields · synced Jul 16, 2026
- FDA UDI e441c1a9-bcd5-4dd4-91f5-d39578adb521 36 fields · synced May 30, 2026