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Neofuser Twin
EUDAMEDClass IIb (EU MDR)
Ref M50-TRef I50-TRef M70-TRef S130-TRef M130-TRef S60-TRef X100-TRef L70-TRef G50-TRef G20-TRef M100-TRef L20-TRef X10-TRef G100-TRef L10-TRef L60-TRef M05-TRef M80-TRef S50-TRef G80-TRef L50-TRef X20-TRef L15-TRef S40-TRef L40-TRef X15-TRef M15-TRef G40-TRef S70-TRef S05-TRef G70-TRef S20-TRef X80-TRef S15-T
Identity
- Trade Name
- Neofuser Twin EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- M50-T EUDAMEDI50-T EUDAMEDM70-T EUDAMEDS130-T EUDAMEDM130-T EUDAMEDS60-T EUDAMEDX100-T EUDAMEDL70-T EUDAMEDG50-T EUDAMEDG20-T EUDAMEDM100-T EUDAMEDL20-T EUDAMEDX10-T EUDAMEDG100-T EUDAMEDL10-T EUDAMEDL60-T EUDAMEDM05-T EUDAMEDM80-T EUDAMEDS50-T EUDAMEDG80-T EUDAMEDL50-T EUDAMEDX20-T EUDAMEDL15-T EUDAMEDS40-T EUDAMEDL40-T EUDAMEDX15-T EUDAMEDM15-T EUDAMEDG40-T EUDAMEDS70-T EUDAMEDS05-T EUDAMEDG70-T EUDAMEDS20-T EUDAMEDX80-T EUDAMEDS15-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027788286 EUDAMED08800027788354 EUDAMED08800331589975 EUDAMED08800027788248 EUDAMED08800027788316 EUDAMED08800331589937 EUDAMED08800027788484 EUDAMED08800331530038 EUDAMED08800027788514 EUDAMED08800331531677 EUDAMED08800027788309 EUDAMED08800027788392 EUDAMED08800331531615 EUDAMED08800027788538 EUDAMED08800331531585 EUDAMED08800331530021 EUDAMED08800331531547 EUDAMED08800027788293 EUDAMED08800027788231 EUDAMED08800027788521 EUDAMED08800027788415 EUDAMED08800331531639 EUDAMED08800331531592 EUDAMED08800027788224 EUDAMED08800027788408 EUDAMED08800331531622 EUDAMED08800027788262 EUDAMED08800027788507 EUDAMED08800331589944 EUDAMED08800331589906 EUDAMED08800331530090 EUDAMED08800027788200 EUDAMED08800027788477 EUDAMED08800027788194 EUDAMED
- Basic UDI-DI
- B-08800027788286 EUDAMEDB-08800027788354 EUDAMEDB-08800331589975 EUDAMEDB-08800027788248 EUDAMEDB-08800027788316 EUDAMEDB-08800331589937 EUDAMEDB-08800027788484 EUDAMEDB-08800331530038 EUDAMEDB-08800027788514 EUDAMEDB-08800331531677 EUDAMEDB-08800027788309 EUDAMEDB-08800027788392 EUDAMEDB-08800331531615 EUDAMEDB-08800027788538 EUDAMEDB-08800331531585 EUDAMEDB-08800331530021 EUDAMEDB-08800331531547 EUDAMEDB-08800027788293 EUDAMEDB-08800027788231 EUDAMEDB-08800027788521 EUDAMEDB-08800027788415 EUDAMEDB-08800331531639 EUDAMEDB-08800331531592 EUDAMEDB-08800027788224 EUDAMEDB-08800027788408 EUDAMEDB-08800331531622 EUDAMEDB-08800027788262 EUDAMEDB-08800027788507 EUDAMEDB-08800331589944 EUDAMEDB-08800331589906 EUDAMEDB-08800331530090 EUDAMEDB-08800027788200 EUDAMEDB-08800027788477 EUDAMEDB-08800027788194 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 Twin 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-08800027788286 | 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 (34)
- EUDAMED 69f7a0e2-dab6-4f1b-ade5-96ae9db6f503 61 fields · synced Sep 17, 2026
- EUDAMED 14367b4a-ea29-40c9-8a76-6099a5d7a104 61 fields · synced May 11, 2026
- EUDAMED 18d03939-3680-46e7-b250-5d9ad7b904df 61 fields · synced May 11, 2026
- EUDAMED 8a7be064-4a4c-4993-92b2-a821dda44f92 61 fields · synced May 16, 2026
- EUDAMED 9c9dc9fe-c288-415e-9882-ce31c48296b0 61 fields · synced May 16, 2026
- EUDAMED d6fae55d-244a-4804-a7fa-f4ed37fc042c 61 fields · synced May 16, 2026
- EUDAMED b46b2a13-b6a1-43bc-9b7f-7110c7e7b783 61 fields · synced May 16, 2026
- EUDAMED ab721191-03cb-4735-89d5-55b2e42bee9e 61 fields · synced May 17, 2026
- EUDAMED f522d567-4275-4b9b-839c-5cafe67969bd 61 fields · synced May 17, 2026
- EUDAMED 667fcd2d-9bbd-4e8b-b954-45aa370ffec0 61 fields · synced May 17, 2026
- EUDAMED 7190a0cc-cb08-4108-a9bd-947c78e29ab9 61 fields · synced May 17, 2026
- EUDAMED 4dbbcf7f-92e5-4f3b-83fd-e4e5a34ab9b0 61 fields · synced May 17, 2026
- EUDAMED 4908be2c-d6dc-4493-b1e7-7ed442afd842 61 fields · synced May 17, 2026
- EUDAMED 0d699fd2-f733-4ae0-afe3-6ff293572071 61 fields · synced May 17, 2026
- EUDAMED 737285f0-ebd1-4af9-bbc0-9b2ecc5a8f0a 61 fields · synced May 17, 2026
- EUDAMED fcbc7c17-d910-4db2-bd50-f01967a3e93e 61 fields · synced May 17, 2026
- EUDAMED 3fe74ef0-9be6-4d68-b633-955c03748c09 61 fields · synced May 17, 2026
- EUDAMED 0c6c958f-e750-4146-a768-da7a9147fbfc 61 fields · synced May 17, 2026
- EUDAMED 05983885-9dd3-4ebc-ab34-82fe961a851a 61 fields · synced May 17, 2026
- EUDAMED 1f76b283-2b16-4eb4-bee7-891036d7dc6a 61 fields · synced May 18, 2026
- EUDAMED 1ce048f8-157c-4dc7-af2e-2d2145554607 61 fields · synced May 18, 2026
- EUDAMED bcd45460-246d-42e5-a67a-0b81e42d34c6 61 fields · synced May 18, 2026
- EUDAMED 4166dfee-dd0d-478c-a26e-232b56f7cd00 61 fields · synced May 18, 2026
- EUDAMED 1ad04b63-e247-4b34-961d-ed7a4bbdd4ec 61 fields · synced May 18, 2026
- EUDAMED c1a15259-cda5-49eb-a3a5-22261de2c30f 61 fields · synced May 18, 2026
- EUDAMED ca7ed480-439f-41bd-827c-cc530832f9df 61 fields · synced May 18, 2026
- EUDAMED 6d7f4534-2f8c-46eb-bc4e-55e0f9dfa3e3 61 fields · synced May 18, 2026
- EUDAMED 38f65dae-5f0f-4bc3-a134-7a21eb39c7a6 61 fields · synced May 18, 2026
- EUDAMED d5a1cbe9-3e56-4f71-acec-c0f7194b8434 61 fields · synced May 18, 2026
- EUDAMED 3ca838f2-9e5f-42e2-8929-d3e9548ddbb3 61 fields · synced May 18, 2026
- EUDAMED 2c978b84-4652-4ed9-9d44-b94bb8acdb85 61 fields · synced May 18, 2026
- EUDAMED fdbd4368-7364-4dbc-9af1-e0edbf6b8482 61 fields · synced May 18, 2026
- EUDAMED c5e6c9a8-464e-4b1d-8dd2-3f06ef789c2c 61 fields · synced May 18, 2026
- EUDAMED 730b6bb1-a11c-46bb-b353-d02bb6549054 61 fields · synced May 19, 2026