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gammaCore Sapphire 6-Month Evaluation Device Kit

by electroCore, Inc.

Ref 12016-02003

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081520302Sapphire43 Basic UDI-DI 00815203022847UDI-DIDate25 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
gammaCore Sapphire
Model / Reference
12016-02003
Primary DI / UDI-DI
00815203022847
Basic UDI-DI
081520302Sapphire43
EMDN Code
Z12101106 Neurological stimulators
Device Class
Class IIa
Medical Purpose
indicated to be used for the treatment and / or prevention of primary headache (migraine and cluster headache) in adults.

Manufacturer details

EUDAMED SRN
US-PR-000049586

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Properties

Other properties (1)

  • Sterile: No