Identity
- Trade Name
- Soft-Release-ST FDA UDI
- Generic Name
- Ambulatory insulin infusion pump, electronic FDA UDI
- Device Name
- Soft Release-ST EUDAMEDSoft-Release-ST 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
- SR112 EUDAMEDFDA UDI
- Description
- Soft-Release-ST 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
- 08809220580413 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809220580413 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 — 10.7 Gram FDA UDIOuter Diameter — 1.5 Millimeter FDA UDINeedle Gauge — 24 Gauge FDA UDILength — 700 Millimeter FDA UDI
Soft Release-ST 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-08809220580413 | 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 (2)
- EUDAMED f50307fb-0525-43a0-8ce7-dd657bd60130 61 fields · synced Jul 24, 2026
- FDA UDI 3df84461-7a80-42a5-8503-094a9442ee44 35 fields · synced May 29, 2026