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HT Supreme

by Sino Medical Sciences Technology Inc. 42 variants

Ref BMA-4.5040Model BMA-2.2510

Active European Union

CE MDR

Valid until

1 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2261877TD01 Date11 Jun 2025IssuedStatusActive expires 1 Nov 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2261877CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    17 Apr 2025
    Expires
    1 Nov 2028
    Reason
    Mnf ar change
  • 2261877TD01 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    11 Jun 2025
    Expires
    1 Nov 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
HT Supreme Drug Coated Coronary Stent System
Model / Reference
BMA-2.2510, BMA-4.5040
Primary DI / UDI-DI
06948546208662
Basic UDI-DI
694854621800M3
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008764
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Sino Medical Sciences Technology Inc.

See all devices from Sino Medical Sciences Technology Inc. →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (10)

  • 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