Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilators EUDAMED
- Model / Reference
- SH300，SH320 EUDAMEDSH320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953204300923 EUDAMED
- Basic UDI-DI
- 69532043SH300SF8 EUDAMED
- Direct Marketing DI
- 06953204300923 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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
Ventilator by Beijing Eternity Electronic Technology Co., Ltd — Class IIb — 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 | 69532043SH300SF8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Eternity Electronic Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000011708
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0d24396d-8ffa-4d76-b1a9-90b487631991 61 fields · synced Jun 19, 2026