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BD Intermittent RTU12C

by Hangzhou Bever Medical Devices Co., Ltd.

Ref RTU12C

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

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 Number69487962TC0003SN Basic UDI-DI 06948796203981UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06948796203981 UDI-DI Date23 Jan 2021ListedStatusListed 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1061-2026 FDA Class II initiated 29 Nov 2025

    Labeling error, Incorrect expiration date

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  • Withdrawn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
BD Ready-to-Use Hydrophilic Catheter EUDAMED
BD Intermittent GUDID
Generic Name
Single-administration urethral drainage catheter
Device Name
Ready-to-Use Hydrophilic Catheter
Model / Ref / Catalog
RTU12C
Primary DI / UDI-DI
06948796203981
Basic UDI-DI
69487962TC0003SN
510(k) Number
FDA Product Code
GBM, EZD
EMDN Code
U01010601 Tiemann catheters, self-lubricating
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 12 French
Catheter Length — 16 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Single-administration urethral drainage catheter

Cleared under the same submission (K192468)

Other devices from Hangzhou Bever Medical Devices Co., Ltd.

See all devices from Hangzhou Bever Medical Devices Co., Ltd. →

Properties

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