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miniRUMEL™ 080995

by LSI Solutions, Inc.

Ref 080995Model 080990

miniRUMEL™ 080995 is a device classified as Class IIa in the EU and Class I in the US made by LSI Solutions, Inc., registered in EUDAMED on 18 Jun 2026 (Basic UDI-DI 0850200006miniRUMELW7) and listed in FDA GUDID since 9 Oct 2020 (UDI-DI 00850200006988), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850200006miniRUMELW7 Basic UDI-DI 00850200006988UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850200006988 UDI-DI Date9 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850200006miniRUMELW7 registered 18 Jun 2026 Active
  • FDA GUDID UDI-DI 00850200006988 listed 9 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850200006988
  2. Registered EUDAMED 0850200006miniRUMELW7

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  • Withdrawn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
miniRUMEL®, 25cm EUDAMED
miniRUMEL™ GUDID
Generic name
Suture/ligature tightener, single-use
Device name
miniRUMEL®, 15cm
Model / Ref / Catalog
080995, 080990
Primary DI / UDI-DI
00850200006988
Basic UDI-DI
0850200006miniRUMELW7
FDA product code
DWS
EMDN code
H900899 Single-use instruments for sutures - other
GMDN term
Suture/ligature tightener, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
870.4500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 25 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Suture/ligature tightener, single-use

Similar devices in this category

Other devices filed under SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER.

Other devices from LSI Solutions, Inc.

See all devices from LSI Solutions, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)