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Flexible Reamers System 1

by Orthofix SRL 7 variants

Ref 17200201Model Accessory

Flexible Reamers System 1 (17200201) is a Class I device made by Orthofix SRL, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 805050436Accssry1NA3Q) and listed in FDA GUDID since 23 Jul 2026 (UDI-DI 18059015378375), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Accssry1NA3Q Basic UDI-DI 18059015378375UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18059015378375 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805050436Accssry1NA3Q registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 18059015378375 listed 23 Jul 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 18059015378375
  2. Registered EUDAMED 805050436Accssry1NA3Q

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  • Withdrawn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
Flexible Reamer EUDAMED
Flexible Reamers System GUDID
Generic name
Instrument tray, reusable
Model / Ref / Catalog
Accessory, 17200201, 1
Primary DI / UDI-DI
18059015378375
Basic UDI-DI
805050436Accssry1NA3Q
Direct marketing DI
18059015378375
FDA product code
FSM
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Accessory
17200201
GUDID
1

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)