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Bonopty Adapter

by AprioMed AB

Ref 250

Bonopty Adapter (250) is a Class I device made by Apriomed AB, registered in EUDAMED on 9 May 2025 (Basic UDI-DI 73500313518KW) and listed in FDA GUDID since 24 Apr 2023 (UDI-DI 07350031350487), 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 Number73500313518KW Basic UDI-DI 07350031350487UDI-DIDate9 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07350031350487 UDI-DI Date24 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 73500313518KW registered 9 May 2025 Active
  • FDA GUDID UDI-DI 07350031350487 listed 24 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350031350487
  2. Registered EUDAMED 73500313518KW

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  • Withdrawn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

Generic name
Surgical instrument handle grip
Device name
Bonopty Adapter 1:3 Revolutions
Model / Ref / Catalog
250, G048
Primary DI / UDI-DI
07350031350487
Basic UDI-DI
73500313518KW
FDA product code
HXY
EMDN code
A018099 Needles - other accessories
GMDN term
Surgical instrument handle grip
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
250
GUDID
G048

Manufacturer details

EUDAMED SRN
SE-MF-000001013

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Category: Electromagnetic surgical navigation device tracking system

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)