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Easy Release
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SU317Ref SU302Model SU301Ref SU311 10boxModel SU313 10boxRef SU312 10boxRef SU303 10boxRef SU318 10boxRef SU319 10boxRef ER0770Ref ER0645Ref ER0690Ref ER1170Ref ER0670
Identity
- Trade Name
- Easy Release FDA UDI
- Generic Name
- Ambulatory insulin infusion pump, electronic FDA UDI
- Device Name
- Easy Release EUDAMEDEasy Release 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
- SU317 EUDAMEDSU301 EUDAMEDFDA UDISU302 EUDAMEDFDA UDISU313 10box EUDAMEDSU311 10box EUDAMEDSU312 10box EUDAMEDSU303 10box EUDAMEDSU318 10box EUDAMEDSU319 10box EUDAMEDER0770 EUDAMEDER0645 EUDAMEDER0690 EUDAMEDER1170 EUDAMEDER0670 EUDAMED
- Description
- Easy Release 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
- 08809220580291 EUDAMED08809220580086 EUDAMEDFDA UDI08809220580567 EUDAMED08809220580574 EUDAMED08809220580550 EUDAMED08809220580635 EUDAMED08809220580642 EUDAMED08809220582202 EUDAMED08809220582073 EUDAMED08809220582318 EUDAMED08809220582219 EUDAMED08809220582196 EUDAMED08809220580178 FDA UDI
- Basic UDI-DI
- B-08809220580291 EUDAMEDB-08809220580086 EUDAMEDB-08809220580567 EUDAMEDB-08809220580574 EUDAMEDB-08809220580550 EUDAMEDB-08809220580635 EUDAMEDB-08809220580642 EUDAMEDB-08809220582202 EUDAMEDB-08809220582073 EUDAMEDB-08809220582318 EUDAMEDB-08809220582219 EUDAMEDB-08809220582196 EUDAMED
- 510(k) Number
- K022317 FDA UDI
- FDA Product Code
- LZG FDA UDI
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ambulatory insulin infusion pump, electronic 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
Yes
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
Dimensions & Sizes
- Size
- Weight — 6.4 Gram FDA UDIOuter Diameter — 1.5 Millimeter FDA UDINeedle Gauge — 27 Gauge FDA UDILength — 100 Millimeter FDA UDI
Easy Release by Sooil Development Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809220580291 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809220580291 | 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 (14)
- EUDAMED b92cefb5-91be-4205-b30d-406133b33b4a 61 fields · synced Sep 18, 2026
- EUDAMED f8f49af4-c561-474c-ab07-84e7759cab57 61 fields · synced May 16, 2026
- EUDAMED d6466051-d5e5-4879-966a-cb12fb4e3cb3 61 fields · synced May 17, 2026
- EUDAMED bb71dc58-54f8-4efd-8837-8b801573d4f8 61 fields · synced May 18, 2026
- EUDAMED 09d8b09c-790a-47a0-904c-a441e00d1571 61 fields · synced May 18, 2026
- EUDAMED 943c10b7-2778-4faf-aef9-b5453e4038ca 61 fields · synced May 18, 2026
- EUDAMED 1cb39366-7d46-4c19-adf7-72ebc8bdca3c 61 fields · synced May 18, 2026
- FDA UDI d754b73d-0889-489d-b1c8-726e1f24ca06 35 fields · synced May 30, 2026
- FDA UDI 092b62c2-e1ee-4936-ab28-5d74ddf161c5 35 fields · synced May 30, 2026
- EUDAMED 03db58d0-5592-4644-9591-94a56cbc68de 61 fields · synced Jul 9, 2026
- EUDAMED 07257c7a-478d-40a8-8feb-d26dcac1e058 61 fields · synced Jul 10, 2026
- EUDAMED 3193ab21-2d93-4c5e-a7b6-43226cfaea12 61 fields · synced Jul 18, 2026
- EUDAMED 6bcc527f-8ce7-484f-b1ce-a0d8a3ff1fe8 61 fields · synced Jul 24, 2026
- EUDAMED 5666283e-8abe-424d-a60b-8b515cbea557 61 fields · synced Aug 5, 2026