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Ecor

EUDAMED

Class IIa (EU MDR)

Ref 10016-20302Model gammaCore Sapphire Device Kit 31-days

by ElectroCore, Inc.

Identity

Trade Name: ECOR EUDAMED
Device Name: gammaCore Sapphire EUDAMED
Model / Reference: gammaCore Sapphire Device Kit 31-days EUDAMED
10016-20302 EUDAMED

Identifiers

Primary DI / UDI-DI: 00815203020195 EUDAMED
Basic UDI-DI: B-00815203020195 EUDAMED
EMDN Code: Z12101106 NEUROLOGICAL STIMULATORS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: France 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

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: ElectroCore, Inc.
EUDAMED SRN: US-MF-000036987
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (1)

EUDAMED edca0e94-5e42-428c-b226-64aaa788c39a 61 fields · synced Jun 18, 2026