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Endobronchial Blocker Tube

by Hangzhou Tappa Medical Technology Co, Ltd. EUDAMED510(k)GUDID

Active European Union and United States

Ref EBT0207, EBT0209, EBT0105, EBT0207S, EBT0109, EBT0209S, EBT0205

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberD-EBT0207PZ UDI-DIDate26 Jun 2026ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK251950 Date20 Mar 2026IssuedStatusActive
European UnionCE/MDR EUDAMED NumberB-EBT0207PZ Basic UDI-DIDate28 Oct 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-EBT0207PZ Basic UDI-DIDate28 Oct 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Endobronchial Blocker Tube EUDAMED
Na GUDID
Generic Name
Endobronchial tube
Model / Ref / Catalog
EBT0207, EBT0209, EBT0105, EBT0207S, EBT0109, EBT0209S, EBT0205
Primary DI / UDI-DI
D-EBT0207PZ, D-EBT0209Q5, D-EBT0105PQ, D-EBT0207S7U, D-EBT0109PY, D-EBT0209S82, D-EBT0205PV, 06950456307960, 06950456307984, 06950456307977, 06950456307946, 06950456307922, 06950456307885
Basic UDI-DI
B-EBT0207PZ, B-EBT0209Q5, B-EBT0105PQ, B-EBT0207S7U, B-EBT0109PY, B-EBT0209S82, B-EBT0205PV, 69504563EBT2N
510(k) Number
FDA Product Code
CBI
EMDN Code
R010499 One lung ventilation devices (olv) - other
GMDN Term
Endobronchial tube
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5740
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000027753
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Hangzhou Tappa Medical Technology Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No