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Basic Sterilization Case Set OPCA1491

by Brain Navi Biotechnology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref OPCA1491

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719878695480 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719878695480 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Basic Sterilization Case Set
Generic Name
Stereotactic neuronavigation/planning system
Model / Reference
OPCA1491
Primary DI / UDI-DI
04719878695480
Basic UDI-DI
B-04719878695480
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)

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Properties

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

Other properties (18)

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