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NeuroHawk

by MicroPort NeuroTech (Shanghai) Co., Ltd. 2 variants

Ref AIS4025

NeuroHawk (AIS4025) is a Class III device made by MicroPort NeuroTech (Shanghai) Co., Ltd., registered in EUDAMED on 30 Jun 2025 (Basic UDI-DI 69586980T0048U4) with CE/MDR certificate 1000323760 valid until 12 Feb 2030, active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

12 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000323760 Date8 Jul 2026IssuedStatusActive expires 12 Feb 2030

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000245870 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    5 Jun 2025
    Expires
    4 Jun 2030
  • 1000323760 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    8 Jul 2026
    Expires
    12 Feb 2030
    Reason
    Add device or group

Timeline

5 dated events

  1. Certificate issued EUDAMED 1000245870
  2. Registered EUDAMED 69586980T0048U4
  3. Certificate issued EUDAMED 1000323760
  4. Certificate expires EUDAMED 1000323760
  5. Certificate expires EUDAMED 1000245870

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
NeuroHawk Thrombectomy Device
Model / reference
AIS4025
Primary DI / UDI-DI
06958698024065
Basic UDI-DI
69586980T0048U4
EMDN code
C019010 Intravascular recanalisation systems
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007053
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Similar devices in this category

Other devices filed under INTRAVASCULAR RECANALISATION SYSTEMS.

Other devices from MicroPort NeuroTech (Shanghai) Co., Ltd.

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    Class III

  • Numen

    Class III

  • Numen

    Class III

See all devices from MicroPort NeuroTech (Shanghai) Co., Ltd. →

Properties

  • Supplied sterile
Other properties (13, all answered No)