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Balloon Inflation Devices

by BrosMed Medical Co., Ltd

Ref BM-BID-II30

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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
United StatesGUDID listing GUDID Number06958481494044 UDI-DI Date13 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-06958481494044 Basic UDI-DI 06958481494044UDI-DIDate22 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06958481494044 Basic UDI-DI 06958481494044UDI-DIDate22 Nov 2021RegisteredStatusActive

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Balloon Inflation Device
Generic Name
Catheter/overtube balloon inflator, single-use
Device Name
Balloon Inflation Devices
Model / Ref / Catalog
BM-BID-II30, rev 01
Primary DI / UDI-DI
06958481494044 EUDAMED
06941466829177 GUDID
Basic UDI-DI
B-06958481494044, 695848140023M3
FDA Product Code
PTM
EMDN Code
Z12030301, C0699
GMDN Term
Catheter/overtube balloon inflator, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BM-BID-II30
GUDID
rev 01
Primary DI / UDI-DIEUDAMED
06958481494044
GUDID
06941466829177
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000007501
Authorised representative
Brosmed Medical B.V. NL-AR-000002616

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No