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Archimedes Sheath

by Broncus Medical, Inc.

Ref 10007

Archimedes Sheath (10007) is a bronchoscopic catheter (EU MDD Class IIa; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Broncus Medical Inc., registered in EUDAMED on 5 Mar 2025 (Basic UDI-DI B-00856571007067), cleared under FDA 510(k) K131234 on 15 Oct 2013 and listed in FDA GUDID since 27 Jun 2017 (UDI-DI 00856571007067), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00856571007067 Basic UDI-DI 00856571007067UDI-DIDate5 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00856571007067 UDI-DI Date27 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131234 Date15 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00856571007067 registered 5 Mar 2025 Active
  • FDA 510(k) K131234 decided 15 Oct 2013 Active
  • FDA GUDID UDI-DI 00856571007067 listed 27 Jun 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131234
  2. Listed FDA GUDID 00856571007067
  3. Registered EUDAMED B-00856571007067

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Bronchoscopic catheter
Model / Ref / Catalog
10007
Primary DI / UDI-DI
00856571007067
Basic UDI-DI
B-00856571007067
510(k) Number
FDA product code
EOQ
EMDN code
R0799 Broncopulmonary endoscopy devices, single-use - other
GMDN term
Bronchoscopic catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 2.0 Millimeter
Outer Diameter — 2.6 Millimeter

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.

Manufacturer details

EUDAMED SRN
US-MF-000027543
Authorised representative
MedDevConsult GmbH DE-AR-000005877

Similar devices in this category

Other devices filed under BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER.

Other devices from Broncus Medical Inc.

See all devices from Broncus Medical Inc. →

Properties

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