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Cervical Trial 4 x 16 mm 8°

by NGMedical GmbH EUDAMEDGUDID

Active European Union

Ref I067

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42516314TD020IIa4W Basic UDI-DIDate23 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04251631411680 UDI-DIDate17 Aug 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR 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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Cervical Trial 4 x 16 mm 8° EUDAMED
Bee GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Cervical Trial
Model / Ref / Catalog
I067, Cervical Trial 4 x 16 mm 8°
Primary DI / UDI-DI
04251631411680
Basic UDI-DI
42516314TD020IIa4W
Direct Marketing DI
04251631411680
510(k) Number
FDA Product Code
LXH
EMDN Code
L1199 Neurosurgery instruments, reusable - other
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
I067
GUDID
Cervical Trial 4 x 16 mm 8°
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000000204

Other devices from NGMedical GmbH

See all devices from NGMedical GmbH →

Properties

  • Reusable
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

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