Hispa
by Guangdong Hispa Med Co., Ltd. 25 variants
Ref S12-03Model see Appendix I Model
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 | Number697784948008TJ 06977849480550 | Date3 Mar 2025 | 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- Withdrawn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
- Device Name
- Drainage Suction Equipment
- Model / Reference
- see Appendix I Model, S12-03
- Primary DI / UDI-DI
- 06977849480550
- Basic UDI-DI
- 697784948008TJ
- EMDN Code
- A060199 Surgical drainage systems - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000045399
- Authorised representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Other devices from Guangdong Hispa Med 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