Skip to content

Apollo PTCA Balloon Dilation Catheter

by BrosMed Medical Co., Ltd 2 variants

Ref 802-2008

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-06958481413014 Basic UDI-DI 06958481413014UDI-DIDate12 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06958481413014 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Apollo Balloon Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Device Name
Apollo PTCA Balloon Dilation Catheter
Model / Ref / Catalog
802-2008 EUDAMED
rev 01 GUDID
802-2008U GUDID
Primary DI / UDI-DI
06958481413014
Basic UDI-DI
B-06958481413014
510(k) Number
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
802-2008
GUDID
rev 01
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

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 (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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