← Back to catalogue
Ecor
EUDAMEDClass IIa (EU MDR)
Ref 12016-07002 VModel gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card)
Identity
- Trade Name
- ECOR EUDAMED
- Device Name
- gammaCore Sapphire SLC EUDAMED
- Model / Reference
- gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card) EUDAMED12016-07002 V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815203020836 EUDAMED
- Basic UDI-DI
- B-00815203020836 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia 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
Category: Point aesthesiometer
Ecor by ElectroCore, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Point aesthesiometer.
- 3mm Standard Ball Tip Stimulating Probe — Rhythmlink International, LLC · Class IIa
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
- PinPrick PP07 128mN — MRC SYSTEMS GMBH MEDIZINTECHNISCHE SYSTEME · Class I
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
- PinPrick PP07 32mN — MRC SYSTEMS GMBH MEDIZINTECHNISCHE SYSTEME · Class I
- PLEXYGON — VYGON ITALIA SRL · Class IIa
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
- EPTE BIPOLAR tDCS — IONCLINICS & DEIONIC, S.L. · Class IIa
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-00815203020836 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ElectroCore, Inc.
- EUDAMED SRN
- US-MF-000036987
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2d2591f3-251a-4d39-8cc9-b0d2e822308b 61 fields · synced Jun 19, 2026