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Superline
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SU001-10boxRef SU002Ref SU204-10boxRef SU202Ref SU003-10boxRef SU203Ref SU201-10boxRef SU002-10boxRef SU102-10boxRef SU102-100boxRef SU101-10boxRef SU204
Identity
- Trade Name
- Superline FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Superline EUDAMEDSuperline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel. FDA UDI
- Model / Reference
- SU001-10box EUDAMEDSU002 EUDAMEDFDA UDISU204-10box EUDAMEDSU202 EUDAMEDSU003-10box EUDAMEDSU203 EUDAMEDSU201-10box EUDAMEDSU002-10box EUDAMEDSU102-10box EUDAMEDSU102-100box EUDAMEDSU101-10box EUDAMEDSU204 EUDAMED
- Description
- Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18809220580434 EUDAMED08809220580017 EUDAMEDFDA UDI08809220580529 EUDAMED08809220580215 EUDAMED08809220580451 EUDAMED08809220580222 EUDAMED08809220580499 EUDAMED08809220580444 EUDAMED08809220580482 EUDAMED18809220581325 EUDAMED18809220581318 EUDAMED08809220582813 EUDAMED
- Basic UDI-DI
- B-18809220580434 EUDAMEDB-08809220580017 EUDAMEDB-08809220580529 EUDAMEDB-08809220580215 EUDAMEDB-08809220580451 EUDAMEDB-08809220580222 EUDAMEDB-08809220580499 EUDAMEDB-08809220580444 EUDAMEDB-08809220580482 EUDAMEDB-18809220581325 EUDAMEDB-18809220581318 EUDAMEDB-08809220582813 EUDAMED
- 510(k) Number
- K022317 FDA UDI
- FDA Product Code
- LZG FDA UDI
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Superline by Sooil Development Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18809220580434 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SOOIL Development Co., Ltd.
- EUDAMED SRN
- KR-MF-000008627
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (13)
- EUDAMED 22fef021-2c1e-4f2f-b982-994584f07fa5 61 fields · synced Aug 1, 2026
- EUDAMED fefff758-658b-4b93-bf2d-43e9c2769538 61 fields · synced May 16, 2026
- EUDAMED 0a49b4f5-0ed8-4c35-92f5-ba46ea143003 61 fields · synced May 17, 2026
- EUDAMED 7952decd-83a6-476a-804f-3d7b5280984c 61 fields · synced May 17, 2026
- EUDAMED b622439a-62d4-42c1-b12c-2d4a67ea1324 61 fields · synced May 18, 2026
- EUDAMED feee58aa-a90d-4287-9e01-401dffd36d6b 61 fields · synced May 18, 2026
- EUDAMED b2295acc-4044-4c57-ba4c-d99dc18e36d8 61 fields · synced May 18, 2026
- EUDAMED 8e06b5bb-129b-4051-bce3-db8af506c26e 61 fields · synced May 18, 2026
- FDA UDI ac19d0eb-5595-445a-8834-2d14bfbc6cd8 34 fields · synced May 30, 2026
- EUDAMED 37e87d6d-d6e4-490e-80a2-1fe74893cf74 61 fields · synced Jul 21, 2026
- EUDAMED ad3e45f6-2356-4db1-af9a-5b7f5b3a680c 61 fields · synced Jul 26, 2026
- EUDAMED 5a3d8cdc-7c9c-48f7-8a98-3ac2ad0829d8 61 fields · synced Jul 29, 2026
- EUDAMED 5b173dc3-0856-4805-9987-1b62480022fc 61 fields · synced Aug 1, 2026