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Neofuser DFO
EUDAMEDClass IIb (EU MDR)
Ref M50-DFORef S60-DFORef G10-DFORef S10-DFORef L70-DFORef I40-DFORef X40-DFORef S30-DFORef M40-DFORef L20-DFORef G50-DFORef S40-DFORef M10-DFORef I70-DFORef G60-DFORef G40-DFORef G70-DFORef I10-DFORef I30-DFORef M60-DFORef G20-DFORef X70-DFORef L50-DFORef X10-DFO
Identity
- Trade Name
- Neofuser DFO EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- M50-DFO EUDAMEDS60-DFO EUDAMEDG10-DFO EUDAMEDS10-DFO EUDAMEDL70-DFO EUDAMEDI40-DFO EUDAMEDX40-DFO EUDAMEDS30-DFO EUDAMEDM40-DFO EUDAMEDL20-DFO EUDAMEDG50-DFO EUDAMEDS40-DFO EUDAMEDM10-DFO EUDAMEDI70-DFO EUDAMEDG60-DFO EUDAMEDG40-DFO EUDAMEDG70-DFO EUDAMEDI10-DFO EUDAMEDI30-DFO EUDAMEDM60-DFO EUDAMEDG20-DFO EUDAMEDX70-DFO EUDAMEDL50-DFO EUDAMEDX10-DFO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027755790 EUDAMED08800331620883 EUDAMED08800331621156 EUDAMED08800027755349 EUDAMED08800331621071 EUDAMED08800331620975 EUDAMED08800331621118 EUDAMED08800331620876 EUDAMED08800027755745 EUDAMED08800331621026 EUDAMED08800331621194 EUDAMED08800331610044 EUDAMED08800331620906 EUDAMED08800331621002 EUDAMED08800331621200 EUDAMED08800331621187 EUDAMED08800331621217 EUDAMED08800331620944 EUDAMED08800331620968 EUDAMED08800331620920 EUDAMED08800331621163 EUDAMED08800331621149 EUDAMED08800331621057 EUDAMED08800331621088 EUDAMED
- Basic UDI-DI
- B-08800027755790 EUDAMEDB-08800331620883 EUDAMEDB-08800331621156 EUDAMEDB-08800027755349 EUDAMEDB-08800331621071 EUDAMEDB-08800331620975 EUDAMEDB-08800331621118 EUDAMEDB-08800331620876 EUDAMEDB-08800027755745 EUDAMEDB-08800331621026 EUDAMEDB-08800331621194 EUDAMEDB-08800331610044 EUDAMEDB-08800331620906 EUDAMEDB-08800331621002 EUDAMEDB-08800331621200 EUDAMEDB-08800331621187 EUDAMEDB-08800331621217 EUDAMEDB-08800331620944 EUDAMEDB-08800331620968 EUDAMEDB-08800331620920 EUDAMEDB-08800331621163 EUDAMEDB-08800331621149 EUDAMEDB-08800331621057 EUDAMEDB-08800331621088 EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
Neofuser DFO by S&S Med Co., Ltd. — Class IIb — MDD — 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
- 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
- SMARTeZ RS-PainBloc-Fixed Flow Rate 80-5-16h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800027755790 | Class IIb | Active |
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Manufacturer
- Manufacturer
- S&S Med Co., Ltd.
- EUDAMED SRN
- KR-MF-000017308
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (24)
- EUDAMED 0196ae11-68c4-4a23-9b08-084f907f7221 61 fields · synced Sep 17, 2026
- EUDAMED 0ca6fb17-b969-475a-8ec8-701eada46b67 61 fields · synced May 16, 2026
- EUDAMED 6e7eeabe-7c0a-4997-8fbd-6f9babc94e2c 61 fields · synced May 16, 2026
- EUDAMED 7f438d9c-a492-4249-b938-85dcc740736c 61 fields · synced May 16, 2026
- EUDAMED 496148b7-8105-409c-9385-84b5d79a54a2 61 fields · synced May 16, 2026
- EUDAMED f419422f-33bf-403b-8b19-2f1fa77db3c0 61 fields · synced May 16, 2026
- EUDAMED f8ee9bab-9aeb-4473-be3d-d83ccdc0b361 61 fields · synced May 17, 2026
- EUDAMED 12764f88-81db-48d4-b7b5-41dda00ae996 61 fields · synced May 17, 2026
- EUDAMED 3c7fb559-20a6-4b1f-ad62-0c43481b4c15 61 fields · synced May 17, 2026
- EUDAMED 89ef0b76-f230-40d4-b162-d6f69130b42f 61 fields · synced May 17, 2026
- EUDAMED 6ea4fb53-aab2-49de-8d41-d2a16bdf4d1f 61 fields · synced May 17, 2026
- EUDAMED 0b4b77b0-4fab-4137-8656-d87a46aa7941 61 fields · synced May 17, 2026
- EUDAMED c58c82dc-c276-443e-a282-8e9b6a9643e1 61 fields · synced May 18, 2026
- EUDAMED aeba0e32-2397-4119-94ad-ac76dead3e7d 61 fields · synced May 18, 2026
- EUDAMED 553b4a59-36cd-418e-a7ee-0fcef557b49e 61 fields · synced May 18, 2026
- EUDAMED c7ae4581-942e-4af8-98d5-8c3e30da72e8 61 fields · synced May 18, 2026
- EUDAMED 865e4ea8-f1fe-424a-aefa-489fdcd48bc0 61 fields · synced May 18, 2026
- EUDAMED a23413a2-121d-4021-b915-854c845739c4 61 fields · synced May 18, 2026
- EUDAMED 5fadce7e-7484-41d0-8ed4-85e860c503b3 61 fields · synced May 18, 2026
- EUDAMED 28131c0b-8221-46f4-a132-5f0458b79474 61 fields · synced May 18, 2026
- EUDAMED 662c273a-445d-40b3-b42c-130bd2a42ffc 61 fields · synced May 19, 2026
- EUDAMED a4f00583-e1f0-4bc9-ba60-77ad0816fd86 61 fields · synced May 19, 2026
- EUDAMED f2a70fbf-3614-4bfd-9f4d-d08d24858645 61 fields · synced May 19, 2026
- EUDAMED 6165ee46-794a-4ba4-93ed-fbdaf0cbb1a5 61 fields · synced May 19, 2026