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Single use flexible ureteroscope

by Shenzhen Besdata Technology Co., Ltd 4 variants

Ref UR-D1Model UR-D1,UR-D2,UR-F1,UR-F2,UR-F3,UR-F4,UR-F5,UR-F6,UR-F8,UR-F9

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971355350673 UDI-DI Date2 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69713553502088E Basic UDI-DI 06971355350673UDI-DIDate10 Nov 2025RegisteredStatusActive

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 24 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  • Withdrawn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
Single use flexible ureteroscope EUDAMED
Besdata GUDID
Generic Name
Flexible video ureteroscope, single-use
Model / Reference
UR-D1, UR-D2, UR-F1, UR-F2, UR-F3, UR-F4, UR-F5, UR-F6, UR-F8, UR-F9
Primary DI / UDI-DI
06971355350673
Basic UDI-DI
69713553502088E
510(k) Number
FDA Product Code
FGB
EMDN Code
Z12020713 Ureterorenoscopes
GMDN Term
Flexible video ureteroscope, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000018921
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Flexible video ureteroscope, single-use

Other devices from Shenzhen Besdata Technology Co., Ltd

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Properties

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

Other properties (19)

  • 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