Sterile Co-Ablation Probe
by Hygea Medical Technology Co., Ltd. United States EUDAMED
Ref NAModel Elite(RAL30/RAS30/RBL26/RAL26/RBS26/RAS26/RBL20/RBS20/RCL17/RCS17/ABL20/ABS20/ACL17/ACS17), Elite ABL20
EMDN Z120102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number69356506KBD0060G4 | Date24 Oct 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Sterile Co-Ablation ProbeCryosurgical Probe
- Model / Reference
- Elite(RAL30/RAS30/RBL26/RAL26/RBS26/RAS26/RBL20/RBS20/RCL17/RCS17/ABL20/ABS20/ACL17/ACS17), NA, Elite ABL20
- Primary DI / UDI-DI
- 06935650600666
- Basic UDI-DI
- 69356506KBD0060G4, B-06935650600666
- EMDN Code
- Z120102 Cryosurgery equipment
- Device Class
- Class IIaClass IIb
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000023128
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Hygea Medical Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (2)
- EUDAMED 1d915af9-e45b-4e41-826e-8d5c2cfa2c9a
- EUDAMED 06935650600666|B-06935650600666