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Monarch 277030115

by Medos International Sàrl

Part of a family of 26 devices: see the family page

Ref 277030115Model Expedium Osteosynthesis Reusable Instruments

Monarch 277030115 is a Class I device made by Medos International Sàrl, registered in EUDAMED on 17 Dec 2025 (Basic UDI-DI 0705034a001085R) and listed in FDA GUDID since 31 Dec 2016 (UDI-DI 10705034196626), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001085R Basic UDI-DI 10705034196626UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034196626 UDI-DI Date31 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705034a001085R registered 17 Dec 2025 Active
  • FDA GUDID UDI-DI 10705034196626 listed 31 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705034196626
  2. Registered EUDAMED 0705034a001085R

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  • Withdrawn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
Monarch Spine System EUDAMED
Monarch GUDID
Generic name
Bone approximation clamp
Device name
Expedium Bender Clamp Rod Claim Spreader Template Wire Twister
Model / Ref / Catalog
277030115, Expedium Osteosynthesis Reusable Instruments
Primary DI / UDI-DI
10705034196626
Basic UDI-DI
0705034a001085R
Direct marketing DI
10705034196626
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Bone approximation clamp
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)