Identity
- Trade Name
- Starling EUDAMEDFDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- STARLING SENSORS EUDAMEDThe Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function. FDA UDI
- Model / Reference
- CMS10 EUDAMEDFDA UDI
- Description
- The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function. FDA UDI
Identifiers
- Catalog Number
- CMS10 FDA UDI
- Primary DI / UDI-DI
- 27290013030041 EUDAMEDFDA UDI
- Basic UDI-DI
- 13003000000000000000077PH EUDAMED
- Unit of Use DI
- 07290013030047 EUDAMED
- 510(k) Number
- K101487 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12050585 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Starling by Cheetah Medical (israel) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 13003000000000000000077PH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cheetah Medical (Israel) Ltd
- EUDAMED SRN
- IL-MF-000037744
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 2dc89521-72e2-4169-b999-091d175d941f 61 fields · synced Jun 8, 2026
- FDA UDI fa04042d-8e6d-40c5-bf9f-dc9f52c73452 36 fields · synced May 30, 2026