SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow rate 1-7 ml/h with Hanger Cap
by Epic International (Thailand) Co., Ltd. Thailand EUDAMED
Ref 486050HC EMDN A05010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88592991B001U4 | Date25 May 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Elastomeric Pump
- Model / Reference
- 486050HC
- Primary DI / UDI-DI
- 18859299112319
- Basic UDI-DI
- 88592991B001U4
- EMDN Code
- A05010201 Elastomeric systems - variable flow w/o additional bolus
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- TH-MF-000012102
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED cb65b19e-dcb2-4085-bd99-2812195eb881