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Neofuser Bolus
EUDAMEDClass IIb (EU MDR)
Ref L0007RRef X0001ERef G0060RRef G0005WRef I0003ERef M0005WRef M0005RRef X0005ERef G0006RRef I0010WRef X0007RRef S0007WRef G0060WRef M0005ERef L0003WRef I0006RRef X0060ERef X0015RRef X0015ERef G0010WRef I0006ERef S0015WRef I0010RRef M0015WRef G0007RRef M0060WRef L0060RRef I0001ERef S0010ERef I0005WRef X0001WRef M0001ERef M0008ERef S0007RRef L0015ERef L0006ERef X0006ERef S0030WRef S0005WRef G0030ERef S0060ERef M0001WRef L0006RRef L0015RRef M0007RRef I0007WRef G0001RRef S0006WRef X0005WRef S0001ERef I0008RRef L0010ERef S0001WRef G0003ERef S0060WRef X0001RRef X0030RRef G0008WRef G0015ERef G0003WRef L0001ERef X0008WRef S0005RRef L0008RRef X0006RRef M0060RRef G0030WRef G0001WRef M0007ERef G0005ERef X0030WRef I0015WRef I0015RRef G0005RRef L0015WRef M0003RRef S0015ERef S0006ERef X0003RRef M0030RRef M0008WRef M0030ERef S0006RRef L0010WRef S0060RRef S0005ERef L0007ERef G0010ERef X0006WRef I0060RRef G0007ERef G0001ERef G0007WRef X0030ERef I0030WRef I0008WRef S0030ERef L0006WRef S0001RRef I0003RRef M0010ERef M0015RRef I0030RRef M0015ERef I0006W
Identity
- Trade Name
- Neofuser Bolus EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMEDSingler Use Infusion Pump EUDAMED
- Model / Reference
- L0007R EUDAMEDX0001E EUDAMEDG0060R EUDAMEDG0005W EUDAMEDI0003E EUDAMEDM0005W EUDAMEDM0005R EUDAMEDX0005E EUDAMEDG0006R EUDAMEDI0010W EUDAMEDX0007R EUDAMEDS0007W EUDAMEDG0060W EUDAMEDM0005E EUDAMEDL0003W EUDAMEDI0006R EUDAMEDX0060E EUDAMEDX0015R EUDAMEDX0015E EUDAMEDG0010W EUDAMEDI0006E EUDAMEDS0015W EUDAMEDI0010R EUDAMEDM0015W EUDAMEDG0007R EUDAMEDM0060W EUDAMEDL0060R EUDAMEDI0001E EUDAMEDS0010E EUDAMEDI0005W EUDAMEDX0001W EUDAMEDM0001E EUDAMEDM0008E EUDAMEDS0007R EUDAMEDL0015E EUDAMEDL0006E EUDAMEDX0006E EUDAMEDS0030W EUDAMEDS0005W EUDAMEDG0030E EUDAMEDS0060E EUDAMEDM0001W EUDAMEDL0006R EUDAMEDL0015R EUDAMEDM0007R EUDAMEDI0007W EUDAMEDG0001R EUDAMEDS0006W EUDAMEDX0005W EUDAMEDS0001E EUDAMEDI0008R EUDAMEDL0010E EUDAMEDS0001W EUDAMEDG0003E EUDAMEDS0060W EUDAMEDX0001R EUDAMEDX0030R EUDAMEDG0008W EUDAMEDG0015E EUDAMEDG0003W EUDAMEDL0001E EUDAMEDX0008W EUDAMEDS0005R EUDAMEDL0008R EUDAMEDX0006R EUDAMEDM0060R EUDAMEDG0030W EUDAMEDG0001W EUDAMEDM0007E EUDAMEDG0005E EUDAMEDX0030W EUDAMEDI0015W EUDAMEDI0015R EUDAMEDG0005R EUDAMEDL0015W EUDAMEDM0003R EUDAMEDS0015E EUDAMEDS0006E EUDAMEDX0003R EUDAMEDM0030R EUDAMEDM0008W EUDAMEDM0030E EUDAMEDS0006R EUDAMEDL0010W EUDAMEDS0060R EUDAMEDS0005E EUDAMEDL0007E EUDAMEDG0010E EUDAMEDX0006W EUDAMEDI0060R EUDAMEDG0007E EUDAMEDG0001E EUDAMEDG0007W EUDAMEDX0030E EUDAMEDI0030W EUDAMEDI0008W EUDAMEDS0030E EUDAMEDL0006W EUDAMEDS0001R EUDAMEDI0003R EUDAMEDM0010E EUDAMEDM0015R EUDAMEDI0030R EUDAMEDM0015E EUDAMEDI0006W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027785193 EUDAMED08800027785322 EUDAMED08800027785490 EUDAMED08800027785629 EUDAMED08800027785094 EUDAMED08800027785025 EUDAMED08800027784967 EUDAMED08800027785346 EUDAMED08800027785438 EUDAMED08800027770038 EUDAMED08800027785315 EUDAMED08800027784936 EUDAMED08800027785698 EUDAMED08800027769346 EUDAMED08800027785254 EUDAMED08800027769612 EUDAMED08800027771028 EUDAMED08800027770786 EUDAMED08800027770960 EUDAMED08800027785667 EUDAMED08800027769797 EUDAMED08800027701063 EUDAMED08800027769674 EUDAMED08800027701360 EUDAMED08800027785445 EUDAMED08800027769582 EUDAMED08800027770304 EUDAMED08800027785087 EUDAMED08800027701018 EUDAMED08800027785148 EUDAMED08800027785360 EUDAMED08800027784981 EUDAMED08800027701308 EUDAMED08800027784875 EUDAMED08800027770427 EUDAMED08800027770335 EUDAMED08800027770878 EUDAMED08800027769148 EUDAMED08800027782703 EUDAMED08800027785582 EUDAMED08800027769032 EUDAMED08800027785001 EUDAMED08800027770151 EUDAMED08800027770243 EUDAMED08800027784974 EUDAMED08800027785155 EUDAMED08800027785407 EUDAMED08800027701032 EUDAMED08800027785384 EUDAMED08800027784882 EUDAMED08800027769643 EUDAMED08800027770397 EUDAMED08800027784912 EUDAMED08800027785513 EUDAMED08800027769179 EUDAMED08800027785285 EUDAMED08800027770816 EUDAMED08800027785650 EUDAMED08800027785575 EUDAMED08800027785612 EUDAMED08800027785209 EUDAMED08800027771080 EUDAMED08800027784868 EUDAMED08800027770182 EUDAMED08800027770694 EUDAMED08800027769315 EUDAMED08800027785681 EUDAMED08800027785605 EUDAMED08800027784998 EUDAMED08800027785520 EUDAMED08800027771172 EUDAMED08800027770069 EUDAMED08800027769704 EUDAMED08800027785421 EUDAMED08800027770601 EUDAMED08800027784950 EUDAMED08800027701025 EUDAMED08800027700998 EUDAMED08800027785292 EUDAMED08800027769285 EUDAMED08800027701346 EUDAMED08800027769452 EUDAMED08800027703838 EUDAMED08800027770571 EUDAMED08800027768912 EUDAMED08800027782697 EUDAMED08800027785230 EUDAMED08800027785568 EUDAMED08800027771059 EUDAMED08800027769766 EUDAMED08800027785544 EUDAMED08800027785506 EUDAMED08800027785636 EUDAMED08800027770991 EUDAMED08800027770090 EUDAMED08800027770007 EUDAMED08800027769001 EUDAMED08800027770519 EUDAMED08800027784844 EUDAMED08800027785056 EUDAMED08800027701315 EUDAMED08800027701285 EUDAMED08800027769735 EUDAMED08800027701322 EUDAMED08800027769971 EUDAMED
- Basic UDI-DI
- B-08800027785193 EUDAMEDB-08800027785322 EUDAMEDB-08800027785490 EUDAMEDB-08800027785629 EUDAMEDB-08800027785094 EUDAMEDB-08800027785025 EUDAMEDB-08800027784967 EUDAMEDB-08800027785346 EUDAMEDB-08800027785438 EUDAMEDB-08800027770038 EUDAMEDB-08800027785315 EUDAMEDB-08800027784936 EUDAMEDB-08800027785698 EUDAMEDB-08800027769346 EUDAMEDB-08800027785254 EUDAMEDB-08800027769612 EUDAMEDB-08800027771028 EUDAMEDB-08800027770786 EUDAMEDB-08800027770960 EUDAMEDB-08800027785667 EUDAMEDB-08800027769797 EUDAMEDB-08800027701063 EUDAMEDB-08800027769674 EUDAMEDB-08800027701360 EUDAMEDB-08800027785445 EUDAMEDB-08800027769582 EUDAMEDB-08800027770304 EUDAMEDB-08800027785087 EUDAMEDB-08800027701018 EUDAMEDB-08800027785148 EUDAMEDB-08800027785360 EUDAMEDB-08800027784981 EUDAMEDB-08800027701308 EUDAMEDB-08800027784875 EUDAMEDB-08800027770427 EUDAMEDB-08800027770335 EUDAMEDB-08800027770878 EUDAMEDB-08800027769148 EUDAMEDB-08800027782703 EUDAMEDB-08800027785582 EUDAMEDB-08800027769032 EUDAMEDB-08800027785001 EUDAMEDB-08800027770151 EUDAMEDB-08800027770243 EUDAMEDB-08800027784974 EUDAMEDB-08800027785155 EUDAMEDB-08800027785407 EUDAMEDB-08800027701032 EUDAMEDB-08800027785384 EUDAMEDB-08800027784882 EUDAMEDB-08800027769643 EUDAMEDB-08800027770397 EUDAMEDB-08800027784912 EUDAMEDB-08800027785513 EUDAMEDB-08800027769179 EUDAMEDB-08800027785285 EUDAMEDB-08800027770816 EUDAMEDB-08800027785650 EUDAMEDB-08800027785575 EUDAMEDB-08800027785612 EUDAMEDB-08800027785209 EUDAMEDB-08800027771080 EUDAMEDB-08800027784868 EUDAMEDB-08800027770182 EUDAMEDB-08800027770694 EUDAMEDB-08800027769315 EUDAMEDB-08800027785681 EUDAMEDB-08800027785605 EUDAMEDB-08800027784998 EUDAMEDB-08800027785520 EUDAMEDB-08800027771172 EUDAMEDB-08800027770069 EUDAMEDB-08800027769704 EUDAMEDB-08800027785421 EUDAMEDB-08800027770601 EUDAMEDB-08800027784950 EUDAMEDB-08800027701025 EUDAMEDB-08800027700998 EUDAMEDB-08800027785292 EUDAMEDB-08800027769285 EUDAMEDB-08800027701346 EUDAMEDB-08800027769452 EUDAMEDB-08800027703838 EUDAMEDB-08800027770571 EUDAMEDB-08800027768912 EUDAMEDB-08800027782697 EUDAMEDB-08800027785230 EUDAMEDB-08800027785568 EUDAMEDB-08800027771059 EUDAMEDB-08800027769766 EUDAMEDB-08800027785544 EUDAMEDB-08800027785506 EUDAMEDB-08800027785636 EUDAMEDB-08800027770991 EUDAMEDB-08800027770090 EUDAMEDB-08800027770007 EUDAMEDB-08800027769001 EUDAMEDB-08800027770519 EUDAMEDB-08800027784844 EUDAMEDB-08800027785056 EUDAMEDB-08800027701315 EUDAMEDB-08800027701285 EUDAMEDB-08800027769735 EUDAMEDB-08800027701322 EUDAMEDB-08800027769971 EUDAMED
- EMDN Code
- A05010102 ELASTOMERIC SYSTEMS - FIXED FLOW WITH 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
Neofuser Bolus by S&S Med Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800027785193 | 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 (105)
- EUDAMED 25528d83-088c-40d5-a9d0-37c71e15c452 61 fields · synced Sep 17, 2026
- EUDAMED 2e59c22b-62ee-4678-8541-23e50390952d 61 fields · synced May 11, 2026
- EUDAMED a3fbea92-e862-45b7-90c2-325ab0a256af 61 fields · synced May 11, 2026
- EUDAMED c0b61dc0-c2df-4251-8af4-e4c2005850db 61 fields · synced May 11, 2026
- EUDAMED 0ef2685a-b613-4abd-b9e3-fe1f2d9855e0 61 fields · synced May 11, 2026
- EUDAMED 141ff9cd-e75f-4bcf-a390-7aa40db240ed 61 fields · synced May 11, 2026
- EUDAMED 93750827-f72b-4f94-8c32-08ef465e08aa 61 fields · synced May 16, 2026
- EUDAMED 96348df3-5dd2-485d-a290-7346744ef928 61 fields · synced May 16, 2026
- EUDAMED e8611cf2-8a22-4865-82b6-a85f3ccc61be 61 fields · synced May 16, 2026
- EUDAMED 73721ce8-46bd-48c7-a7ac-db01a862a771 61 fields · synced May 16, 2026
- EUDAMED 3443e994-a533-4851-b9d2-be86c5b1dba6 61 fields · synced May 16, 2026
- EUDAMED bcc7bef4-70b1-44cc-8a29-0b321622eec9 61 fields · synced May 16, 2026
- EUDAMED 428c5d3a-9b4b-489c-ad35-9edd3b876005 61 fields · synced May 16, 2026
- EUDAMED 7c452070-46af-41cd-ae22-306cfcfb3df4 61 fields · synced May 16, 2026
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- EUDAMED 96bb5970-cfda-4c2e-ae67-64a275b3882b 61 fields · synced May 16, 2026
- EUDAMED 20ff9b74-ba39-4833-af7b-4e49629623c0 61 fields · synced May 16, 2026
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- EUDAMED 98148120-7d99-4777-956e-a48c1235740b 61 fields · synced May 17, 2026
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- EUDAMED 244d7757-43d4-41d3-9985-fc3292780091 61 fields · synced May 18, 2026
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- EUDAMED b8641b7a-cf89-4f21-958a-4ad431d51480 61 fields · synced May 19, 2026
- EUDAMED 449b6a49-b84b-4654-95bc-26af01ad4646 61 fields · synced May 19, 2026