Identity
- Trade Name
- SMARTeZ Pump KVO 100-0.5-200h EUDAMEDSMARTeZ Pump KVO FDA UDI
- Generic Name
- Elastomeric infusion pump system FDA UDI
- Device Name
- Elastomeric Pump EUDAMEDSMARTeZ Pump KVO 100-0.5-200h FDA UDI
- Model / Reference
- 498111 EUDAMEDFDA UDI
- Description
- SMARTeZ Pump KVO 100-0.5-200h FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28859299198112 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B001U4 EUDAMED
- 510(k) Number
- K242152 FDA UDI
- FDA Product Code
- MEB FDA UDI
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
- GMDN Term
- Elastomeric infusion pump system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Elastomeric infusion pump system
SMARTeZ Pump KVO by Epic International(thailand) Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump system.
- SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
- Halyard — Avanos Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI f88b2cdf-3821-46b1-a09a-08f5fdea54c2 34 fields · synced Jul 24, 2026
- EUDAMED 4d26c9f2-919b-4ae7-bbd8-1dda06730bb6 61 fields · synced Jul 24, 2026