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
- SU313 EUDAMEDFDA UDI
- 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
- 08809220580253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809220580253 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 — 9.5 Gram FDA UDIOuter Diameter — 1.5 Millimeter FDA UDINeedle Gauge — 27 Gauge FDA UDILength — 700 Millimeter FDA UDI
Easy Release 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 Unknown
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809220580253 | Class IIa | Unknown |
| 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 (2)
- EUDAMED 6bad01eb-37dd-41a8-a41c-7e9678460979 61 fields · synced May 30, 2026
- FDA UDI 4690791a-e9ca-4de6-bba7-e27ae6dea68b 35 fields · synced May 29, 2026