Cardiologs Platform
Ref 2.4.XModel 2.4
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++G637CEASK | Date24 Sep 2024 | StatusActive |
| United States | GUDID listing GUDID | Number++G637CEA0 | Date23 Sep 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Cardiopulmonary physiological parameter analysis software, professional-only
- Model / Reference
- 2.4, 2.4.X
- Primary DI / UDI-DI
- ++G637CEA0 EUDAMED+G637CEA0 EUDAMEDG637CEA0 GUDID
- Basic UDI-DI
- ++G637CEASK
- Direct Marketing DI
- ++G637CEA0+G637CEA0
- 510(k) Number
- FDA Product Code
- DPS, DQK
- EMDN Code
- V9099 Various devices not included in other classes - other
- GMDN Term
- Cardiopulmonary physiological parameter analysis software, professional-only
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.2340, 870.1425
- Special Device Type
- Software
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | ++G637CEA0 +G637CEA0 | G637CEA0 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- FR-MF-000038954
Other devices from Philips France
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No