IVF Workstation
by Hua Yue Medical Technology Co., Ltd. 10 variants
Ref IW-B1800S-PModel IW-A1800,IW-A1800S,IW-A1800M,IW-A1800D,IW-A950,IW-A1350A,IW-A1350C,IW-A1350S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697518390IWA012345674R 06975183900277 | Date24 Mar 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- IW-A1800,IW-A1800S,IW-A1800M,IW-A1800D,IW-A950,IW-A1350A,IW-A1350C,IW-A1350S, IW-B1800S-P
- Primary DI / UDI-DI
- 06975183900277
- Basic UDI-DI
- 697518390IWA012345674R
- Direct Marketing DI
- 06975183900277
- EMDN Code
- U080299 Devices for assisted reproduction - other
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000037345
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Hua Yue Medical Technology Co., Ltd.
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No