Patient Monitor
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 25 variants
Ref Patient MonitorModel cPM 15M, uMEC 30, BeneVision N17
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06903053014984 | Date19 Nov 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number69449040AB010000353H | Date20 Dec 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- ePM 10MA Patient MonitorBeneVision N15 OR Patient Monitor
- Generic Name
- General-purpose multi-parameter bedside monitor
- Device Name
- Patient Monitor
- Model / Reference
- cPM 15M EUDAMEDPatient Monitor EUDAMEDuMEC 30 EUDAMEDBeneVision N17 EUDAMEDePM 10MA GUDIDBeneVision N15 OR GUDID
- Primary DI / UDI-DI
- 06903053014984, 06903053043526, 06936415975906, 06903053015073, 06936415927141, 06903053015035, 06903053015028, 06903053010252
- Basic UDI-DI
- 69449040AB010000353H, 69449040AB010000473Q, 69449040AB0100002136
- FDA Product Code
- MHX
- EMDN Code
- Z1203020201 Multi–parameter patient bedside monitors
- GMDN Term
- General-purpose multi-parameter bedside monitor
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.1025
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | cPM 15M Patient Monitor uMEC 30 BeneVision N17 | ePM 10MA BeneVision N15 OR |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →
Properties
Other properties (20)
- 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
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No