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Neofuser DN
EUDAMEDClass IIb (EU MDR)
Ref M20-DNRef G60-DNRef I20-DNRef L80-DNRef M40-DNRef L100-DNRef S130-DNRef S05-DNRef S30-DNRef X20-DNRef M80-DNRef M130-DNRef I05-DNRef M30-DNRef X130-DNRef X30-DNRef L10-DNRef M05-DNRef I30-DNRef L30-DNRef I130-DNRef I60-DNRef L05-DNRef M60-DNRef S15-DNRef G80-DNRef X80-DNRef M50-DNRef S100-DNRef X10-DNRef X50-DNRef G100-DNRef L50-DNRef M15-DNRef L20-DNRef L70-DNRef S40-DNRef G70-DNRef S70-DNRef I50-DNRef I80-DNRef X60-DNRef I15-DNRef S50-DN
Identity
- Trade Name
- Neofuser DN EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- M20-DN EUDAMEDG60-DN EUDAMEDI20-DN EUDAMEDL80-DN EUDAMEDM40-DN EUDAMEDL100-DN EUDAMEDS130-DN EUDAMEDS05-DN EUDAMEDS30-DN EUDAMEDX20-DN EUDAMEDM80-DN EUDAMEDM130-DN EUDAMEDI05-DN EUDAMEDM30-DN EUDAMEDX130-DN EUDAMEDX30-DN EUDAMEDL10-DN EUDAMEDM05-DN EUDAMEDI30-DN EUDAMEDL30-DN EUDAMEDI130-DN EUDAMEDI60-DN EUDAMEDL05-DN EUDAMEDM60-DN EUDAMEDS15-DN EUDAMEDG80-DN EUDAMEDX80-DN EUDAMEDM50-DN EUDAMEDS100-DN EUDAMEDX10-DN EUDAMEDX50-DN EUDAMEDG100-DN EUDAMEDL50-DN EUDAMEDM15-DN EUDAMEDL20-DN EUDAMEDL70-DN EUDAMEDS40-DN EUDAMEDG70-DN EUDAMEDS70-DN EUDAMEDI50-DN EUDAMEDI80-DN EUDAMEDX60-DN EUDAMEDI15-DN EUDAMEDS50-DN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800331530250 EUDAMED08800331530779 EUDAMED08800331530373 EUDAMED08800331530557 EUDAMED08800331530274 EUDAMED08800331530564 EUDAMED08800331530212 EUDAMED08800331530106 EUDAMED08800331530144 EUDAMED08800331530618 EUDAMED08800331530311 EUDAMED08800331530335 EUDAMED08800331530342 EUDAMED08800331530267 EUDAMED08800331530694 EUDAMED08800331530625 EUDAMED08800331530472 EUDAMED08800331530229 EUDAMED08800331530380 EUDAMED08800331530502 EUDAMED08800331530458 EUDAMED08800331530410 EUDAMED08800331530465 EUDAMED08800331530298 EUDAMED08800331530120 EUDAMED08800331530793 EUDAMED08800331530670 EUDAMED08800331530281 EUDAMED08800331530205 EUDAMED08800331530595 EUDAMED08800331530649 EUDAMED08800331530809 EUDAMED08800331530526 EUDAMED08800331530243 EUDAMED08800331530496 EUDAMED08800331530540 EUDAMED08800331530151 EUDAMED08800331530786 EUDAMED08800331530182 EUDAMED08800331530403 EUDAMED08800331530434 EUDAMED08800331530656 EUDAMED08800331530366 EUDAMED08800331530168 EUDAMED
- Basic UDI-DI
- B-08800331530250 EUDAMEDB-08800331530779 EUDAMEDB-08800331530373 EUDAMEDB-08800331530557 EUDAMEDB-08800331530274 EUDAMEDB-08800331530564 EUDAMEDB-08800331530212 EUDAMEDB-08800331530106 EUDAMEDB-08800331530144 EUDAMEDB-08800331530618 EUDAMEDB-08800331530311 EUDAMEDB-08800331530335 EUDAMEDB-08800331530342 EUDAMEDB-08800331530267 EUDAMEDB-08800331530694 EUDAMEDB-08800331530625 EUDAMEDB-08800331530472 EUDAMEDB-08800331530229 EUDAMEDB-08800331530380 EUDAMEDB-08800331530502 EUDAMEDB-08800331530458 EUDAMEDB-08800331530410 EUDAMEDB-08800331530465 EUDAMEDB-08800331530298 EUDAMEDB-08800331530120 EUDAMEDB-08800331530793 EUDAMEDB-08800331530670 EUDAMEDB-08800331530281 EUDAMEDB-08800331530205 EUDAMEDB-08800331530595 EUDAMEDB-08800331530649 EUDAMEDB-08800331530809 EUDAMEDB-08800331530526 EUDAMEDB-08800331530243 EUDAMEDB-08800331530496 EUDAMEDB-08800331530540 EUDAMEDB-08800331530151 EUDAMEDB-08800331530786 EUDAMEDB-08800331530182 EUDAMEDB-08800331530403 EUDAMEDB-08800331530434 EUDAMEDB-08800331530656 EUDAMEDB-08800331530366 EUDAMEDB-08800331530168 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 DN 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-08800331530250 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S&S Med Co., Ltd.
- EUDAMED SRN
- KR-MF-000017308
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (44)
- EUDAMED 10002832-0a49-470b-97d3-106bdb78c0eb 61 fields · synced Sep 17, 2026
- EUDAMED 47374b58-bc7c-449e-b846-2635a15d1649 61 fields · synced May 11, 2026
- EUDAMED c6963848-d8bb-4d65-ab4a-67886e1adc7d 61 fields · synced May 11, 2026
- EUDAMED 3e8fbe1c-6074-41a6-add2-7d3320e0d5c7 61 fields · synced May 16, 2026
- EUDAMED cfc8a388-4a9d-484c-a3e0-7c5b36f2c9db 61 fields · synced May 16, 2026
- EUDAMED 23d5111b-5921-4a15-bc46-8290c801c3a5 61 fields · synced May 16, 2026
- EUDAMED 944426cc-531c-4ee6-834b-cce4ae4e48ad 61 fields · synced May 16, 2026
- EUDAMED 38a145d0-0a83-46d8-8ea0-1255e62cb5ca 61 fields · synced May 17, 2026
- EUDAMED 24fac9cb-e96a-44d9-a609-59820badb1bd 61 fields · synced May 17, 2026
- EUDAMED 9d9dd422-3267-4a36-973a-29a5d6997292 61 fields · synced May 17, 2026
- EUDAMED 7e7c394e-485d-4a42-b607-75c97ff4e237 61 fields · synced May 17, 2026
- EUDAMED dcfc3842-ed10-4dad-8a77-c601348f28ec 61 fields · synced May 17, 2026
- EUDAMED 9c1d3ce8-2bb3-434a-8b44-fe692cae2d21 61 fields · synced May 17, 2026
- EUDAMED 74b78548-3475-488c-bd4a-bc1fcddb55c1 61 fields · synced May 17, 2026
- EUDAMED 18c71322-e485-402b-95f6-bc5972aa88a5 61 fields · synced May 17, 2026
- EUDAMED 426be989-a7cf-4e1d-a083-bda0b362ded3 61 fields · synced May 17, 2026
- EUDAMED e9f6816b-14eb-4bd1-83ba-c9636522964e 61 fields · synced May 17, 2026
- EUDAMED 26062a61-59e7-4437-baf8-6eae67a29906 61 fields · synced May 17, 2026
- EUDAMED f5390d88-7950-4943-a9bc-037c7c036b09 61 fields · synced May 17, 2026
- EUDAMED bf7fe116-8278-4ab4-b92e-c0c2837c1af5 61 fields · synced May 17, 2026
- EUDAMED a0b28697-bd4c-46f6-b317-b0c4361f8976 61 fields · synced May 18, 2026
- EUDAMED cc973c7b-5f5d-46e3-937a-19ff4ef2dc98 61 fields · synced May 18, 2026
- EUDAMED 524ed8ff-791f-48e1-be18-56e936890ddb 61 fields · synced May 18, 2026
- EUDAMED e88672fb-73b5-4913-9816-a1d5f94eca63 61 fields · synced May 18, 2026
- EUDAMED ad65ee85-f4bb-4d46-b29e-714401528b72 61 fields · synced May 18, 2026
- EUDAMED e084d054-5d39-42f6-b02d-6b9999890888 61 fields · synced May 18, 2026
- EUDAMED 14733b27-1573-4986-bc9e-3486d91b51b8 61 fields · synced May 18, 2026
- EUDAMED 39be6da6-ebf9-490a-8b65-b2a30c1d2115 61 fields · synced May 18, 2026
- EUDAMED 5e41fb3c-4a02-4b68-a3b3-d6216bb9de4c 61 fields · synced May 18, 2026
- EUDAMED e4ac998e-c767-46df-8dd2-b38f1c1c8ee8 61 fields · synced May 18, 2026
- EUDAMED 9c7c8165-b62b-4484-9b4f-bbf04ce44787 61 fields · synced May 18, 2026
- EUDAMED 961ba4aa-be2f-445e-aca4-2b78e2ca041a 61 fields · synced May 18, 2026
- EUDAMED 57f98099-9814-45e1-ad67-22162a4ead9c 61 fields · synced May 18, 2026
- EUDAMED babc1def-52e8-468c-b08e-7c8c9550ccba 61 fields · synced May 18, 2026
- EUDAMED 0c369725-a4b3-4eb7-96dd-78d3b0c57a41 61 fields · synced May 18, 2026
- EUDAMED 48d4b0f5-dda5-4a9c-bddd-55a9f891c79c 61 fields · synced May 18, 2026
- EUDAMED 7bd20b5f-9cc9-4e90-9f97-856adbc0f835 61 fields · synced May 18, 2026
- EUDAMED 48f9ad27-f722-4329-bc3f-dd17dabca25e 61 fields · synced May 18, 2026
- EUDAMED 160a30c4-aec5-4f43-b848-ef9e09cf1af2 61 fields · synced May 18, 2026
- EUDAMED faf01578-c9fe-487a-b559-e1032ad08173 61 fields · synced May 18, 2026
- EUDAMED 5442cd56-eb50-48d7-a3f6-97d50e3fd28c 61 fields · synced May 19, 2026
- EUDAMED a69036f0-9e8d-4040-b902-37a4ccf1d127 61 fields · synced May 19, 2026
- EUDAMED 81a79118-79c5-4991-acfe-f7b10a0d0fbe 61 fields · synced May 19, 2026
- EUDAMED 0f9f4335-2795-4063-8472-546a805a5e79 61 fields · synced May 19, 2026