Zoncare
by Wuhan Zoncare Bio-medical Electronics Co., Ltd 32 variants
Ref /Model Mulan 3, Mulan 3Elite, Mulan 3Ultra, Mulan 2, Mulan 2Elite, Mulan 2Ultra, Mulan 1, Mulan 1Elite, Mulan 1Ultra
Active
CE MDR
Valid until
23 Jun 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695691349601NA 06956913496024 | Date1 Jul 2026 | StatusActive |
Certificates
- FI26/1008026 Active
Quality management system EU MDR
- Certifier
- SGS FIMKO OY 0598
- Issued
- 23 Jun 2026
- Expires
- 23 Jun 2029
- Valid from
- 24 Jun 2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Color Doppler Ultrasound System
- Model / Reference
- Mulan 3, Mulan 3Elite, Mulan 3Ultra, Mulan 2, Mulan 2Elite, Mulan 2Ultra, Mulan 1, Mulan 1Elite, Mulan 1Ultra, /
- Primary DI / UDI-DI
- 06956913496024
- Basic UDI-DI
- 695691349601NA
- EMDN Code
- Z11040103 Portable ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000010439
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wuhan Zoncare Bio-medical Electronics Co., Ltd
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Properties
Other properties (12)
- Sterile: 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