Identity
- Trade Name
- Disposable Oral Protectors for ECT EUDAMEDOral Protector EUDAMED
- Device Name
- VENTIL-A Disposable Oral Protectors for ECT EUDAMEDReusable Oral Protector EMGD EUDAMED
- Model / Reference
- VENT EUDAMEDEMGD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850298007034 EUDAMED00850298007041 EUDAMED
- Basic UDI-DI
- 08502980070395 EUDAMED08502980070497 EUDAMED
- EMDN Code
- R0199 INTUBATION DEVICES - OTHER EUDAMEDQ010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable Oral Protectors for ECT by Somatics, LLC — 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 | 08502980070395 | Class I | Active |
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Manufacturer
- Manufacturer
- Somatics, LLC
- EUDAMED SRN
- US-MF-000011550
- Authorised Representative
- FBI Medizintechnik GmbH DE-AR-000009421
Sources (2)
- EUDAMED 456cd4c3-cb7d-49ff-bfa2-52c8f10325bd 61 fields · synced Jul 29, 2026
- EUDAMED 15cd3219-6d5c-48f4-9e3b-e24888483eff 61 fields · synced Jul 29, 2026