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Ecor
EUDAMEDClass IIa (EU MDR)
Ref 12016-08001Model gammaCore Sapphire SLC Device Kit 31-Days (kit with refill card)
Identity
- Trade Name
- ECOR EUDAMED
- Device Name
- gammaCore Sapphire SLC EUDAMED
- Model / Reference
- gammaCore Sapphire SLC Device Kit 31-Days (kit with refill card) EUDAMED12016-08001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815203021154 EUDAMED
- Basic UDI-DI
- B-00815203021154 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815203021154 | 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 af1d8c8c-1a72-45cb-83ce-e4e8248b4c9d 61 fields · synced Jun 18, 2026