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Easy Release

by SOOIL Development Co., Ltd. 8 variants

Ref SU302Model SU301

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809220580086 Basic UDI-DI 08809220580086UDI-DIDate4 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08809220580086 UDI-DI Date11 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Ambulatory insulin infusion pump, electronic
Model / Reference
SU301, SU302
Primary DI / UDI-DI
08809220580086, 08809220580178
Basic UDI-DI
B-08809220580086
510(k) Number
FDA Product Code
LZG
EMDN Code
Z12030385 Infusion instruments - consumables
GMDN Term
Ambulatory insulin infusion pump, electronic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5725
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 6.4 Gram
Outer Diameter — 1.5 Millimeter
Needle Gauge — 27 Gauge
Length — 100 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000008627
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sooil Development Co., Ltd.

See all devices from Sooil Development Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No