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Replacement AC Power Adapter Blade Kit
EUDAMEDClass IIa (EU MDR)
Ref 20016-00002-RPL
Identity
- Trade Name
- Replacement AC Power Adapter Blade Kit EUDAMED
- Device Name
- gammaCore Sapphire EUDAMED
- Model / Reference
- 20016-00002-RPL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815203022434 EUDAMED
- Basic UDI-DI
- 081520302GAMMACOREL6 EUDAMED
- EMDN Code
- Z12101180 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Replacement AC Power Adapter Blade Kit by ElectroCore, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081520302GAMMACOREL6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ElectroCore, Inc.
- EUDAMED SRN
- US-MF-000036987
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d77d0207-dae3-443c-ac44-ff705322cbc5 61 fields · synced Jul 16, 2026