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Steadyflow
EUDAMEDClass IIb (EU MDR)
Ref ABF0200RModel APORef ALF0050RRef ALF0200R
Identity
- Trade Name
- STEADYFLOW EUDAMED
- Device Name
- STEADYFLOW EUDAMED
- Model / Reference
- APO EUDAMEDABF0200R EUDAMEDALF0050R EUDAMEDALF0200R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052204716548 EUDAMED08052204716357 EUDAMED08052204716388 EUDAMED
- Basic UDI-DI
- 80522047103STEADY2E EUDAMED
- Direct Marketing DI
- 08052204716548 EUDAMED08052204716357 EUDAMED08052204716388 EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
Steadyflow by Adria Med S.r.l. — Class IIb — MDR — listed in 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 (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 | 80522047103STEADY2E | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adria Med S.r.l.
- EUDAMED SRN
- IT-MF-000020866
Sources (3)
- EUDAMED 8c103591-8142-455f-8270-6a20d08b8d48 61 fields · synced Jul 25, 2026
- EUDAMED 03f306fd-3921-4aaa-97bd-eca6d57718d5 61 fields · synced May 17, 2026
- EUDAMED 29f7c4c6-9ce5-4bff-a5a3-ecd3a949100e 61 fields · synced May 17, 2026