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Shp Unt Infinity M540 V2
EUDAMEDClass IIb (EU MDR)
Ref MS41200Model 307028XK13Z020
Identity
- Trade Name
- SHP UNT INFINITY M540 V2 EUDAMED
- Model / Reference
- 307028XK13Z020 EUDAMEDMS41200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675773306 EUDAMED
- Basic UDI-DI
- 040486752307028XK13Z020GT EUDAMED
- Direct Marketing DI
- 04048675773306 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS 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
Shp Unt Infinity M540 V2 by Draeger Medical Systems, Inc. — 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 | 040486752307028XK13Z020GT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000020721
- Authorised Representative
- Drägerwerk AG & Co. KGaA DE-AR-000005330
Sources (1)
- EUDAMED ae0a3d3f-e6c4-4466-bee8-2fc7e428a3f0 61 fields · synced Jun 19, 2026