Identity
- Trade Name
- Ear, Nose & Throat Treatment Units EUDAMED
- Device Name
- Ear, Nose & Throat Treatment Units EUDAMED
- Model / Reference
- ST-E800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974836130139 EUDAMED
- Basic UDI-DI
- B-06974836130139 EUDAMED
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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: ENT examination/treatment system
Ear, Nose & Throat Treatment Units by Foshan Suntem Medical Instrument Co., Ltd — 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-06974836130139 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Suntem Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000018388
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d20974ef-944d-4bc0-bef0-f8e8b7342d69 61 fields · synced Jun 18, 2026