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Hydrophilic Intermittent Catheter 020307

by Hangzhou Bever Medical Devices Co., Ltd.

Ref 020307

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16948796207863 UDI-DI Date7 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69487962TC0002SL Basic UDI-DI 16948796207863UDI-DIDate13 Jul 2026RegisteredStatusActive

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 25 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  • Withdrawn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
Hydrophilic Intermittent Catheter
Generic Name
Single-administration urethral drainage catheter
Model / Reference
020307
Primary DI / UDI-DI
16948796207863
Basic UDI-DI
69487962TC0002SL
510(k) Number
FDA Product Code
GBM
EMDN Code
U01010602 Tiemann catheters, non 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
Greece
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 12 French
Shaft Length — 362 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K111405)

Show all (12)

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
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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