SMARTeZ RS-PainBloc-Variable Flow Volume 270ml flow 2-14ml/h Hanger Cap
by Epic International (Thailand) Co., Ltd.
Ref 478040HC
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 | Number88592991B001U4 18859299115051 | Date25 May 2026 | 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- Withdrawn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
- Elastomeric Pump
- Model / Reference
- 478040HC
- Primary DI / UDI-DI
- 18859299115051
- Basic UDI-DI
- 88592991B001U4
- EMDN Code
- A05010201 Elastomeric systems - variable flow w/o additional bolus
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- TH-MF-000012102
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Epic International (Thailand) Co., Ltd.
See all devices from Epic International (Thailand) Co., Ltd. →
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No