Identity
- Trade Name
- Spectra 360 Electrode Gel EUDAMEDSPECTRA FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Redux Gel EUDAMEDSpectra 360 Electrode Gel, 60 gram tube FDA UDI
- Model / Reference
- 65-04 EUDAMED12-02 EUDAMEDELECTRODE GEL FDA UDI
- Description
- Spectra 360 Electrode Gel, 60 gram tube FDA UDI
Identifiers
- Catalog Number
- 12-02 FDA UDI
- Primary DI / UDI-DI
- 10855683006194 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300612015HJ EUDAMED
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Spectra 360 Electrode Gel 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 | 085568300612015HJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED bd078334-b6d6-4363-a931-dd320a2bfb5a 61 fields · synced Jul 11, 2026
- FDA UDI ef14ac0c-2f81-432e-b2b9-d9ba1c31b5e8 35 fields · synced May 30, 2026