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Ecor

EUDAMED

Class IIa (EU MDR)

Ref 12016-08594Model gammaCore Sapphire SLC Refill Card Evaluation KitRef 12016-08593Model gammaCore Sapphire SLC Refill Card Kit 93-daysRef 12016-07593 VRef 12016-08001 VModel gammaCore Sapphire SLC Device Kit 31-Days (Kit with refill card)Ref 11016-07003Model gammaCore Sapphire D Device Kit 36-Month PreprogrammedRef 12016-02001Model gammaCore Sapphire SLC Device Kit, 31-Days (kit with refill card)Ref 12016-02594Model gammaCore Sapphire SLC Evaluation Refill Card KitRef 12016-02593Ref 12016-08002Model gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card)Ref 12016-02001 VRef 12016-02593 VModel gammaCore Sapphire SLC Refill Card Kit 93-DaysRef 12016-02002 VRef 10016-20302 VModel gammaCore Sapphire Device Kit 31-DaysRef 10016-23131Model gammaCore Sapphire Refill Card Kit 31-daysRef 12016-02531 VModel gammaCore Sapphire SLC Refill Card Kit 31-DaysRef 12016-07531Ref 12016-07003Model gammaCore Sapphire SLC Device Kit for Evaluation (kit with refill card)

by ElectroCore, Inc.

Identity

Trade Name
ECOR EUDAMED
Device Name
gammaCore Sapphire EUDAMED
gammaCore Sapphire SLC EUDAMED
gammaCore Sapphire D EUDAMED
Model / Reference
gammaCore Sapphire SLC Refill Card Evaluation Kit EUDAMED
12016-08594 EUDAMED
gammaCore Sapphire SLC Refill Card Kit 93-days EUDAMED
12016-08593 EUDAMED
12016-07593 V EUDAMED
gammaCore Sapphire SLC Device Kit 31-Days (Kit with refill card) EUDAMED
12016-08001 V EUDAMED
gammaCore Sapphire D Device Kit 36-Month Preprogrammed EUDAMED
11016-07003 EUDAMED
gammaCore Sapphire SLC Device Kit, 31-Days (kit with refill card) EUDAMED
12016-02001 EUDAMED
gammaCore Sapphire SLC Evaluation Refill Card Kit EUDAMED
12016-02594 EUDAMED
12016-02593 EUDAMED
gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card) EUDAMED
12016-08002 EUDAMED
12016-02001 V EUDAMED
12016-02593 V EUDAMED
12016-02002 V EUDAMED
gammaCore Sapphire Device Kit 31-Days EUDAMED
10016-20302 V EUDAMED
gammaCore Sapphire Refill Card Kit 31-days EUDAMED
10016-23131 EUDAMED
gammaCore Sapphire SLC Refill Card Kit 31-Days EUDAMED
12016-02531 V EUDAMED
12016-07531 EUDAMED
gammaCore Sapphire SLC Device Kit for Evaluation (kit with refill card) EUDAMED
12016-07003 EUDAMED

Identifiers

Primary DI / UDI-DI
00815203021390 EUDAMED
00815203021376 EUDAMED
00815203021017 EUDAMED
00815203021161 EUDAMED
00815203021109 EUDAMED
00815203020515 EUDAMED
00815203020904 EUDAMED
00815203020591 EUDAMED
00815203021178 EUDAMED
00815203020713 EUDAMED
00815203020898 EUDAMED
00815203021024 EUDAMED
00815203020720 EUDAMED
00815203020201 EUDAMED
00815203020317 EUDAMED
00815203020881 EUDAMED
00815203020997 EUDAMED
00815203020843 EUDAMED
Basic UDI-DI
B-00815203021390 EUDAMED
B-00815203021376 EUDAMED
B-00815203021017 EUDAMED
B-00815203021161 EUDAMED
B-00815203021109 EUDAMED
B-00815203020515 EUDAMED
B-00815203020904 EUDAMED
B-00815203020591 EUDAMED
B-00815203021178 EUDAMED
B-00815203020713 EUDAMED
B-00815203020898 EUDAMED
B-00815203021024 EUDAMED
B-00815203020720 EUDAMED
B-00815203020201 EUDAMED
B-00815203020317 EUDAMED
B-00815203020881 EUDAMED
B-00815203020997 EUDAMED
B-00815203020843 EUDAMED
EMDN Code
Z12101106 NEUROLOGICAL STIMULATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Denmark EUDAMED
Latvia EUDAMED
Germany EUDAMED
Belgium EUDAMED
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

Similar devices

Also classified as Point aesthesiometer.

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 (18)

  • EUDAMED 655b7299-e30e-4356-b3ac-27644d470ffc 61 fields · synced Jul 30, 2026
  • EUDAMED 07ad183f-6708-4d81-a50d-1888b37361c5 61 fields · synced May 16, 2026
  • EUDAMED 4138390e-4c97-4bf8-8f92-35db96cd1c70 61 fields · synced May 17, 2026
  • EUDAMED 5a54246e-e821-4e41-ad1a-c1635c4545e5 61 fields · synced May 17, 2026
  • EUDAMED d90db81d-4b0a-4b92-8097-2b36e607af34 61 fields · synced May 17, 2026
  • EUDAMED 6dfdc382-bfbd-40ba-9a95-28f5bc21087e 61 fields · synced May 17, 2026
  • EUDAMED 966cdca4-c524-4a5c-b063-569a9bc1d91a 61 fields · synced May 17, 2026
  • EUDAMED 3a443144-830f-49bf-a333-9ca5bf4b43c3 61 fields · synced May 17, 2026
  • EUDAMED 971ff67f-866a-4f2e-8fc0-da5fde8b9c73 61 fields · synced May 17, 2026
  • EUDAMED 7e885371-332a-474a-bbab-82272eed186b 61 fields · synced May 17, 2026
  • EUDAMED f56feb65-c048-41e8-84e1-79fb079f47db 61 fields · synced May 17, 2026
  • EUDAMED d4d5d65b-a41c-44e2-88cf-99bd0d9738a8 61 fields · synced May 17, 2026
  • EUDAMED 5aaa428b-b98a-4587-834a-b7eac0d9dfda 61 fields · synced May 17, 2026
  • EUDAMED 6b535620-ffae-41d8-9235-32c970594c23 61 fields · synced May 18, 2026
  • EUDAMED abfcfd4d-29b4-45b0-86ec-b3bba590b2c6 61 fields · synced May 18, 2026
  • EUDAMED f0787f00-769c-4279-9209-047f6f135639 61 fields · synced May 18, 2026
  • EUDAMED df740260-94bb-44a0-b302-0664aa406eea 61 fields · synced May 19, 2026
  • EUDAMED 17336997-8cc6-402b-aefc-b9a2ee18bc3f 61 fields · synced May 19, 2026