Identity
- Trade Name
- BUTLER GRINDCARE DEVICE EUDAMED
- Device Name
- BUTLER GRINDCARE DEVICE EUDAMED
- Model / Reference
- 99GC401D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630019900161 EUDAMED
- Basic UDI-DI
- B-17630019900161 EUDAMED
- EMDN Code
- Z12062401 ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Butler Grindcare Device by Sunstar Europe SA — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-17630019900161 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sunstar Europe SA
- EUDAMED SRN
- CH-MF-000023162
- Authorised Representative
- Sunstar France FR-AR-000018318
Sources (1)
- EUDAMED fdde6b7d-176d-433e-9a27-f170e33415eb 61 fields · synced Jun 18, 2026