ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS

EMDN A05010102

Parent A050101 ELASTOMERIC SYSTEMS - FIXED FLOW

Registry term list. Not a clinical opinion. 8412 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Bifurcated	18859299105267	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Bifurcated with Hanger Cap	18859299116287	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Bifurcated with Hanger Cap&NRFit	18859299116317	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Bifurcated with NRFit	18859299116294	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Single	18859299105236	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Single Hanger Cap	18859299111954	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Single Hanger Cap&NRFit	18859299112180	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Single NRFit	18859299111725	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single	18859299105151	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single Hanger Cap	18859299111879	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112104	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single NRFit	18859299111640	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 2ml Refill 15 min Single	18859299105168	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 2ml Refill 15min Single Hanger Cap	18859299111886	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112111	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 2ml Refill 15 min Single NRFit	18859299111657	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 15 min Single	18859299105342	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 15 min Single with Hanger Cap	18859299121199	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 15 min Single with Hanger Cap& NRFit	18859299121205	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 15 min Single with NRFit	18859299121212	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 30 min, Single	18859299105281	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 30 min Single with Hanger Cap	18859299119837	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 30 min Single with Hanger Cap&NRFit	18859299119844	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 30 min Single with NRFit	18859299119851	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 60 min, Single	18859299105274	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 60 min Single with Hanger Cap	18859299119790	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 60 min Single with Hanger Cap&NRFit	18859299119806	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 60 min Single with NRFit	18859299119813	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single	18859299105175	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single Hanger Cap	18859299111893	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112128	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single NRFit	18859299111664	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-8ml/h-Bolus 2ml Refill 15 min Single	18859299105182	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-8ml/h-Bolus 2ml Refill 15 min Single Hanger Cap	18859299111909	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-8ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112135	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-8ml/h-Bolus 2ml Refill 15 min Single NRFit	18859299111671	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-10ml/h-Bolus 2ml Refill 15 min Single	18859299105229	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-10ml/h-Bolus 2ml Refill 15 min Single Hanger Cap	18859299111947	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-10ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112173	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-10ml/h-Bolus 2ml Refill 15min Single NRFit	18859299111718	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 15 min Single	18859299105199	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 15 min Single Hanger Cap	18859299111916	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit	18859299112142	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 15min Single NRFit	18859299111688	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 60 min Single	18859299105243	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 60 min Single Hanger Cap	18859299115297	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 60 min Single Hanger Cap&NRFit	18859299115310	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 60 min Single NRFit	18859299115303	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 5ml Refill 15 min Single	18859299105359	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 5ml Refill 15 min Single with Hanger Cap	18859299121229	Epic International (Thailand) Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-11-02 · Link to EUDAMED