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None-sterile X-ray Detectable Laparotomy Sponges

by Hubei V-Medical Products Co., Ltd. 3 variants

Ref 010412-RO

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697023378GauzeSpongesNS7J Basic UDI-DI 16942013216409UDI-DIDate12 Jun 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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
None-sterile X-ray Detectable Laparotomy Sponges非灭菌带X线纱布腹部垫
Model / Reference
010412-RO
Primary DI / UDI-DI
16942013216409
Basic UDI-DI
697023378GauzeSpongesNS7J
Direct Marketing DI
06942013216402
EMDN Code
M0201030202 Laparotomy cotton gauzes, with x-ray detectable thread, non-sterile
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000011268
Authorised representative
RAFFIN MEDICAL FR-AR-000004632

Other devices from Hubei V-Medical Products Co., Ltd.

See all devices from Hubei V-Medical Products Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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