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Single-use Flexible Bronchoscope BC-S1H00

by Hunan Vathin Medical Instrument Co., Ltd

Ref BC-S1H00Model Single-use Flexible Bronchoscope: BC-S1E00, BC-S1H00, BC-S1J00,BC-S1E00-L, BC-S1H00-L, BC-S1J00-L，BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697219748BC2X Basic UDI-DI 06972197483284UDI-DIDate21 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06972197483284 UDI-DI Date23 Dec 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Bc-S1H00 EUDAMED
Single-use Flexible Bronchoscope GUDID
Generic Name
Flexible video bronchoscope, single-use
Model / Reference
BC-S1H00, Single-use Flexible Bronchoscope: BC-S1E00, BC-S1J00, BC-S1E00-L, BC-S1H00-L, BC-S1J00-L，BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL
Primary DI / UDI-DI
06972197483284
Basic UDI-DI
697219748BC2X
510(k) Number
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K241612)

Other devices from Hunan Vathin Medical Instrument Co., Ltd

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Properties

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

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No