Defibrillator/Monitor
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Ref BeneHeart D3, BeneHeart D2, uMED 20A, uMED 20Model BeneHeart D2/BeneHeart D3, uMED 20/uMED 20A
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06944904028019 | Date13 Apr 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- BeneHeart D3, BeneHeart D2/BeneHeart D3, BeneHeart D2, uMED 20/uMED 20A, uMED 20A, uMED 20
- Primary DI / UDI-DI
- 06944904028019, 06936415927479, 06936415973568, 06936415972356
- Basic UDI-DI
- B-06944904028019, B-06936415927479, B-06936415973568, B-06936415972356
- EMDN Code
- Z12030501, Z12030502
- Device Class
- Class IIb
- EU market of registration
- Germany
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 (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No