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Catheter Adaptor FPIH0401

by Brain Navi Biotechnology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref FPIH0401

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719878695145 Basic UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719878695145 UDI-DIDate25 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Catheter Adapt EUDAMED
Catheter Adaptor GUDID
Generic Name
Stereotactic neuronavigation/planning system
Model / Reference
FPIH0401
Primary DI / UDI-DI
04719878695145
Basic UDI-DI
B-04719878695145
510(k) Number
FDA Product Code
HAW
EMDN Code
N018099 Encephalic and peripheral nervous system devices - accessories - other
GMDN Term
Stereotactic neuronavigation/planning system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K242575)

Show all (12)

Other devices from Brain Navi Biotechnology Co., Ltd.

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Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No