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POT PTCA Balloon Dilatation Catheter rev01

by BrosMed Medical Co., Ltd. 7 variants

Ref 833-3512

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

CE MDR CE MDD

Valid until

4 Aug 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR.2292-2026/0055 Date5 Aug 2026IssuedStatusActive expires 4 Aug 2031
European UnionCE/MDD EUDAMED NumberB-06958481467239 Basic UDI-DI 06958481467239UDI-DIDate21 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06958481467239 UDI-DI Date8 May 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0055 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    5 Aug 2026
    Expires
    4 Aug 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Pot EUDAMED
POT PTCA Balloon Dilatation Catheter GUDID
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Ref / Catalog
833-3512, rev01
Primary DI / UDI-DI
06958481467239 EUDAMED
06958481438543 GUDID
Basic UDI-DI
B-06958481467239, 695848140007M5
FDA Product Code
LOX
EMDN Code
C010401020101 Ptca balloon dilation catheters
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.5100
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
833-3512
GUDID
rev01
Primary DI / UDI-DIEUDAMED
06958481467239
GUDID
06958481438543
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Coronary angioplasty balloon catheter, basic

Cleared under the same submission (K230705)

Other devices from BrosMed Medical Co., Ltd.

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

Properties

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

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No