Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- RS300 EUDAMEDRS200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970819423403 EUDAMED
- Basic UDI-DI
- 697081942RS300KU EUDAMED
- Direct Marketing DI
- 06970819423403 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ventilator by Resvent Medical 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 | 697081942RS300KU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Resvent Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012608
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e6ca8f6b-ae74-4b45-b782-0649b84b33aa 61 fields · synced Jun 19, 2026