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Inflation Device

by Shanghai INT Medical Instruments Co., Ltd. 13 variants

Part of a family of 14 devices: see the family page

Ref AI40

Inflation Device (AI40) is a Class I device made by Shanghai INT Medical Instruments Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 69509009CEIDRG), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69509009CEIDRG Basic UDI-DI 06950900920028UDI-DIDate13 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Inflation Device
Model / reference
AI40
Primary DI / UDI-DI
06950900920028
Basic UDI-DI
69509009CEIDRG
EMDN code
C010402020180 PTA balloon dilatation catheters - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009966
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETERS.

Other devices from Shanghai INT Medical Instruments Co., Ltd.

See all devices from Shanghai INT Medical Instruments Co., Ltd. →

Properties

  • Supplied sterile
  • Measuring function
Other properties (12, all answered No)