Identity
- Trade Name
- ECT Mouth Guard (Disposable Bite Block) EUDAMED
- Device Name
- ECT Mouth Guard EUDAMED
- Model / Reference
- GAG-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298000047 EUDAMED
- Basic UDI-DI
- 62622980GAG-1E2 EUDAMED
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECT Mouth Guard (Disposable Bite Block) by Dadeh Gostaran Dena — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62622980GAG-1E2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dadeh Gostaran Dena
- EUDAMED SRN
- IR-MF-000038532
- Authorised Representative
- Eska Diagnostics Kft HU-AR-000037211
Sources (1)
- EUDAMED 4f006b80-4cf1-4cf0-9851-e853dbb641c5 61 fields · synced Jun 19, 2026