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Romeo 2 Instrumentation Ell-in 20 03-N

by Spineart

Ref ELL-IN 20 03-N

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1764045086NAVPLSLEEVE00VQ Basic UDI-DI 07640139349927UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640139349927 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Romeo® 2 Screwdriver Sleeve EUDAMED
Romeo 2 Instrumentation GUDID
Generic Name
Surgical screwdriver, reusable
Device Name
NAVIGATION REUSABLE INSTRUMENTS IIa SLEEVE PLASTIC
Model / Ref / Catalog
ELL-IN 20 03-N
Primary DI / UDI-DI
07640139349927
Basic UDI-DI
1764045086NAVPLSLEEVE00VQ
Direct Marketing DI
07640139349927
FDA Product Code
KWP, MNH, MNI
EMDN Code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN Term
Surgical screwdriver, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3050, 888.3070
EU market of registration
France
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

Category: Surgical screwdriver, reusable

Other devices from Spineart

See all devices from Spineart →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No