← Back to catalogue
SMARTeZ Plus-PainBloc-Fixed Flow Volume 270ml Flow Rate Dual 2+2ml/h with Hange…
EUDAMEDClass IIa (EU MDR)
Ref 483220HC
Identity
- Trade Name
- SMARTeZ Plus-PainBloc-Fixed Flow Volume 270ml Flow Rate Dual 2+2ml/h with Hanger Cap EUDAMED
- Device Name
- Elastomeric Pump EUDAMED
- Model / Reference
- 483220HC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299116706 EUDAMED
- Basic UDI-DI
- 88592991B001U4 EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
SMARTeZ Plus-PainBloc-Fixed Flow Volume 270ml Flow Rate Dual 2+2ml/h with Hange… by Epic International (Thailand) Co., Ltd. — Class IIa — MDR — listed in…
Similar devices
Also classified as Elastomeric infusion pump system.
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- SimplFusor — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED · Class II
- Infusion Pump — Henan Tuoren Medical Device Co., Ltd · Class IIa
- EASYFLOW — Adria Med S.r.l. · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88592991B001U4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epic International (Thailand) Co., Ltd.
- EUDAMED SRN
- TH-MF-000012102
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d1efcb1d-9718-4924-8c96-ef951d5be45e 61 fields · synced Sep 18, 2026