Microwave Ablation Device
by Hygea Medical Technology Co., Ltd.
Model Exceed S10E
Active
CE MDR
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/MDR | Number69356506PMA0270NL 06935650626031 | Date23 Oct 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Microwave Ablation Device
- Model / Reference
- Exceed S10E
- Primary DI / UDI-DI
- 06935650626031
- Basic UDI-DI
- 69356506PMA0270NL
- Direct Marketing DI
- 06935650626031
- EMDN Code
- Z120608 Microwave therapy equipment
- Device Class
- Class IIb
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000023128
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Hygea Medical Technology Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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