Identity
- Trade Name
- Vista Gateway 256 Beds EUDAMED
- Model / Reference
- 107004XK29Z000 EUDAMED2601668 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675663997 EUDAMED
- Basic UDI-DI
- 040486754107004XK29Z000EN EUDAMED
- EMDN Code
- Z12039082 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software 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
Vista Gateway 256 Beds by Shanghai Dräger Medical Instrument Co., Ltd. — 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 | 040486754107004XK29Z000EN | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dräger Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012737
- Authorised Representative
- Drägerwerk AG & Co. KGaA DE-AR-000005330
Sources (1)
- EUDAMED 7e444583-c27e-492b-9648-6326244450d3 61 fields · synced Oct 5, 2026