Patient Monitor
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 25 variants
Ref Patient Monitor, BeneVision N22 ICU, BeneVision N22 OR, BeneVision M19, BeneVision M22CModel uMEC 30, BeneVision N22, BeneVision N1, cPM 15M, BeneVision N22/BeneVision N22 OR/BeneVision N22 ICU/BeneVision N19/BeneVision N19 OR/BeneVision N19 ICU/ BeneVision M22/BeneVision M22C/BeneVision M19/BeneVision M19C, 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 | Number06903053043540 | Date24 Jan 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number69449040AB010000473Q | Date22 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- Withdrawn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
- Patient Monitor EUDAMEDGUDIDBeneVision M17 Patient Monitor GUDIDBeneVision M22C Patient Monitor GUDIDBeneVision N17 OR Patient Monitor GUDIDePM 15MA Patient Monitor GUDIDBeneVision N15 ICU Patient Monitor GUDIDBeneVision M12 Patient Monitor GUDIDBeneVision N22 OR Patient Monitor GUDIDBeneVision N22 Patient Monitor GUDIDBeneVision N22 ICU Patient Monitor GUDID
- Generic Name
- General-purpose multi-parameter bedside monitor
- Model / Reference
- uMEC 30, Patient Monitor, BeneVision N22, BeneVision N1, cPM 15M, BeneVision M22C, BeneVision N22 OR, BeneVision N22 ICU, BeneVision N22/BeneVision N22 OR/BeneVision N22 ICU/BeneVision N19/BeneVision N19 OR/BeneVision N19 ICU/ BeneVision M22/BeneVision M22C/BeneVision M19/BeneVision M19C, BeneVision M19, BeneVision N17, BeneVision M17, BeneVision N17 OR, ePM 15MA, ePM 12M, BeneVision N15 ICU, BeneVision M12, ePM 10
- Primary DI / UDI-DI
- 06903053043540, 06936415975869, 06903053064453, 06903053062305, 06903053010238, 06903053037785, 06936415975944, 06944904095615, 06936415975333, 06936415975920, 06936415927103, 06936415927110, 06936415975890, 06936415927196, 06903053015042, 06903053015080
- Basic UDI-DI
- 69449040AB010000473Q, 69449040AB010000343F, 69449040AB0100002034, 69449040AB010000353H, 69449040AB0100002238, 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 |
|---|---|---|
| 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.
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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