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InnoGrace

by Innolcon Medical Technology (Suzhou) Co., Ltd. China EUDAMED

Ref IBSGPL35Model IBSG22/35/45, IBSGBL22/35/45,IBSGPL22/35/45, ICBSG22/35/45, ICBSGBL22/35/45,ICBSGPL22/35/45,IFBSG22/35/45, IFBSGBL22/35/45, IFBSGPL22/35/45,IFCBSG22/35/45, IFCBSGBL22/35/45, IFCBSGPL22/35/45 EMDN Z12010801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697246494MD03010USS0036X Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Ultrasonic Surgical Scalpel
Model / Reference
IBSG22/35/45, IBSGBL22/35/45, IBSGPL22/35/45, ICBSG22/35/45, ICBSGBL22/35/45, ICBSGPL22/35/45, IFBSG22/35/45, IFBSGBL22/35/45, IFBSGPL22/35/45, IFCBSG22/35/45, IFCBSGBL22/35/45, IFCBSGPL22/35/45, IBSGPL35
Primary DI / UDI-DI
06972464941165
Basic UDI-DI
697246494MD03010USS0036X
EMDN Code
Z12010801 Ultrasonic scalpel
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000012689
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Innolcon Medical Technology (Suzhou) Co., Ltd.

See all devices from Innolcon Medical Technology (Suzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f68b3c51-7e2d-46ec-ac07-f2ed4080b444 61 fields · synced 25 Oct 2026