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SignaGel Branded Electrolyte Gel
EUDAMEDClass I (EU MDR)
Ref 10000-00002Model SignaGel Branded Electrolyte Gel, 60g Tubes 6-Pack
Identity
- Device Name
- SignaGel Branded Electrolyte Gel EUDAMED
- Model / Reference
- SignaGel Branded Electrolyte Gel, 60g Tubes 6-Pack EUDAMED10000-00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815203021895 EUDAMED
- Basic UDI-DI
- B-00815203021895 EUDAMED
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SignaGel Branded Electrolyte Gel by ElectroCore, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815203021895 | Class I | Active |
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Manufacturer
- Manufacturer
- ElectroCore, Inc.
- EUDAMED SRN
- US-MF-000036987
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 808fb166-836b-4133-9aa4-f20e48a4aa2e 61 fields · synced Aug 1, 2026