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SignaSpray Electrode Solution and Skin Prep
EUDAMEDFDA UDIClass I (EU MDR)
Ref 18-28Model Alpha-Stim Conductive Solution
Identity
- Trade Name
- SignaSpray Electrode Solution and Skin Prep EUDAMEDParker Labs FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Alpha-Stim Conductive Solution EUDAMEDSignaspray Electrode Solution, one gallon bottle FDA UDI
- Model / Reference
- Alpha-Stim Conductive Solution EUDAMED18-28 EUDAMEDSignaspray Electrode Solution FDA UDI
- Description
- Signaspray Electrode Solution, one gallon bottle FDA UDI
Identifiers
- Catalog Number
- 18-28 FDA UDI
- Primary DI / UDI-DI
- 10855683006279 EUDAMED00855683006272 FDA UDI
- Basic UDI-DI
- 085568300618000JF EUDAMED
- Unit of Use DI
- 00855683006272 EUDAMED
- 510(k) Number
- K780973 FDA UDI
- FDA Product Code
- GYB FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - 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
- 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
No
FDA UDI
SignaSpray Electrode Solution and Skin Prep 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 dd528d98-ae03-4794-abf4-02ec4e595ea7 61 fields · synced Jul 16, 2026
- FDA UDI 9c0452b2-25c4-4bdf-a1fc-0a4abd0f31d8 36 fields · synced May 30, 2026