DANA Diabecare

FDA UDI

Class II (US FDA UDI)

by Sooil Development Co., Ltd

Identity

Trade Name: DANA Diabecare FDA UDI
Generic Name: Ambulatory insulin infusion pump reservoir FDA UDI
Device Name: DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. FDA UDI
Model / Reference: ⅡS Kits FDA UDI
Description: DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809220581045 FDA UDI
510(k) Number: K022317 FDA UDI
K063126 FDA UDI
K071418 FDA UDI
FDA Product Code: MRZ FDA UDI
LGZ FDA UDI
GMDN Term: Ambulatory insulin infusion pump reservoir FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump, electronic

DANA Diabecare by Sooil Development Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III

Cleared under the same submission

K022317 also covers:

Superline — SOOIL DEVELOPMENT CO., LTD

K063126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sooil Development Co., Ltd

Sources (1)

FDA UDI 30a0b81a-a6da-4ea0-98ae-09758637c029 34 fields · synced May 30, 2026