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LoopView® B58-C

by MacroLux Medical Technology Co., Ltd.

Ref B58-CModel B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG

LoopView® B58-C is a device classified as Class IIa in the EU and Class II in the US made by MacroLux Medical Technology Co., Ltd., registered in EUDAMED on 29 Oct 2025 (Basic UDI-DI 697533962003MN) and listed in FDA GUDID since 31 Oct 2024 (UDI-DI 06975339622268), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697533962003MN Basic UDI-DI 06975339622268UDI-DIDate29 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975339622268 UDI-DI Date31 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697533962003MN registered 29 Oct 2025 Active
  • FDA GUDID UDI-DI 06975339622268 listed 31 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06975339622268
  2. Registered EUDAMED 697533962003MN

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  • Withdrawn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
LoopView EUDAMED
LoopView® GUDID
Generic name
Flexible video bronchoscope, single-use
Model / reference
B58-C, B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG
Primary DI / UDI-DI
06975339622268
Basic UDI-DI
697533962003MN
FDA product code
EOQ
EMDN code
Z12020802 Video bronchoscopes
GMDN term
Flexible video bronchoscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Flexible video bronchoscope, single-use

Similar devices in this category

Other devices filed under VIDEO BRONCHOSCOPES.

Other devices from MacroLux Medical Technology Co., Ltd.

See all devices from MacroLux Medical Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)