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Perla® Nav Drill Guide

by Spineart SA EUDAMEDGUDID

Active European Union

Ref NAV-IN 50 00-N

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1764045086SRI00REUSIN1R3E Basic UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640332471661 UDI-DIDate21 Nov 2025ListedStatusListed 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Perla® Nav Drill Guide EUDAMED
Perla Nav GUDID
Generic Name
Surgical drill guide, reusable
Device Name
SURGICAL REUSABLE INSTRUMENTS Ir
Model / Ref / Catalog
NAV-IN 50 00-N
Primary DI / UDI-DI
07640332471661
Basic UDI-DI
1764045086SRI00REUSIN1R3E
Direct Marketing DI
07640332471661
FDA Product Code
OLO
EMDN Code
L091099 Osteosynthesis instruments, reusable - other
GMDN Term
Surgical drill guide, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000015664
Authorised representative
Alpes CN SAS FR-AR-000013241

Other devices from Spineart SA

See all devices from Spineart SA →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No