Micro sc Infusion Pump
Ref HK101
Active
CE MDD
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/MDD | NumberB-06920712704017 06920712704017 | Date31 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Infusion Pump
- Model / Reference
- HK101
- Primary DI / UDI-DI
- 06920712704017
- Basic UDI-DI
- B-06920712704017
- EMDN Code
- Z12030301 Infusion pumps
- Device Class
- Class IIb
- Market of Registration
- Luxembourg
Manufacturer details
- EUDAMED SRN
- CN-MF-000021761
- Authorised representative
- SciPharm Sàrl LU-AR-000014241
Other devices from Apex Medical Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Measuring Function: No
- Incorporates Medicinal Product: No