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BOBsnare Device 082000

by LSI Solutions, Inc.

Ref 082000

BOBsnare Device 082000 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 0850200006BOBsnareVV) and listed in FDA GUDID since 21 Aug 2025 (UDI-DI 00850012846536), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850200006BOBsnareVV Basic UDI-DI 00850012846536UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850012846536 UDI-DI Date21 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850200006BOBsnareVV registered 18 Jun 2026 Active
  • FDA GUDID UDI-DI 00850012846536 listed 21 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850012846536
  2. Registered EUDAMED 0850200006BOBsnareVV

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  • Withdrawn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
BOBsnare™ Device EUDAMED
BOBsnare Device GUDID
Generic name
Suture/ligature tightener, single-use
Model / Ref / Catalog
082000
Primary DI / UDI-DI
00850012846536
Basic UDI-DI
0850200006BOBsnareVV
FDA product code
MDM
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
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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

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
  • Manufacturing date
Other properties (18, all answered No)