Skip to content

Inflation Device

by Shanghai INT Medical Instruments Co., Ltd. China EUDAMEDGUDID

Ref AI30, AI25, IDK214, INT-ID-243, AI25A, IDK103, AI25M, INT-ID-423, AI25B, IDK205, INT-ID-443, IDK202, INT-ID-236, IDK104, AI25C, INT-ID-446, INT-ID-246, IDK102Model AI25, AI30, AI40

Product code MAVEMDN C010402020180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69509009CEIDRG Basic UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06950900920011 UDI-DIDate15 Aug 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Inflation Device EUDAMED
INT,Force Inflation Device GUDID
Generic Name
Catheter/overtube balloon inflator, single-use
Model / Reference
AI30, AI25, AI40, IDK214, INT-ID-243, AI25A, IDK103, AI25M, INT-ID-423, AI25B, IDK205, INT-ID-443, IDK202, INT-ID-236, IDK104, AI25C, INT-ID-446, INT-ID-246, IDK102
Primary DI / UDI-DI
06950900920011, D-InflationDeviceEL, 06950900920035, 06950900958861, 06942033968671, 06950900961052, 06950900957444, 06942033968657, 06942033968695, 06950900906817, 06950900942556, 06942033968732, 06950900933639, 06942033968664, 06950900957451, 06950900906824, 06942033968749, 06942033968688, 06950900957437
Basic UDI-DI
69509009CEIDRG, B-InflationDeviceEL
510(k) Number
FDA Product Code
MAV
EMDN Code
C010402020180 PTA balloon dilatation catheters - accessories
GMDN Term
Catheter/overtube balloon inflator, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

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

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Measuring Function
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (21)

  • EUDAMED be56b10d-05c5-4369-b28b-df44dad17bda 61 fields · synced 24 Oct 2026
  • EUDAMED D-INFLATIONDEVICEEL|B-INFLATIONDEVICEEL 61 fields · synced 18 May 2026
  • FDA UDI dfbdbfef-ad8f-40d2-b628-4f0eec250777 34 fields · synced 27 May 2026
  • FDA UDI 613b8b4d-8ef4-44a7-bcba-f3612e062bd3 34 fields · synced 30 May 2026
  • EUDAMED 06950900958861|69509009CEIDRG 61 fields · synced 20 Jun 2026
  • EUDAMED 06942033968671|69509009CEIDRG 61 fields · synced 8 Jul 2026
  • EUDAMED 06950900961052|69509009CEIDRG 61 fields · synced 8 Jul 2026
  • EUDAMED 06950900957444|69509009CEIDRG 61 fields · synced 9 Jul 2026
  • EUDAMED 06942033968657|69509009CEIDRG 61 fields · synced 9 Jul 2026
  • EUDAMED 06942033968695|69509009CEIDRG 61 fields · synced 9 Jul 2026
  • EUDAMED 06950900906817|69509009CEIDRG 61 fields · synced 9 Jul 2026
  • EUDAMED 06950900942556|69509009CEIDRG 61 fields · synced 10 Jul 2026
  • EUDAMED 06942033968732|69509009CEIDRG 61 fields · synced 10 Jul 2026
  • EUDAMED 06950900933639|69509009CEIDRG 61 fields · synced 10 Jul 2026
  • EUDAMED 06942033968664|69509009CEIDRG 61 fields · synced 11 Jul 2026
  • EUDAMED 06950900920035|69509009CEIDRG 61 fields · synced 11 Jul 2026
  • EUDAMED 06950900957451|69509009CEIDRG 61 fields · synced 12 Jul 2026
  • EUDAMED 06950900906824|69509009CEIDRG 61 fields · synced 15 Jul 2026
  • EUDAMED 06942033968749|69509009CEIDRG 61 fields · synced 24 Jul 2026
  • EUDAMED 06942033968688|69509009CEIDRG 61 fields · synced 26 Jul 2026
  • EUDAMED 06950900957437|69509009CEIDRG 61 fields · synced 27 Jul 2026