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Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel)

by Huaiyin Medical Instruments Co., Ltd 12 variants

Ref No 13Model Sterile Disposable Surgical Blade with Plastic Handle、Sterile Disposable Surgical Blade

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69385355SurgicalbladeCRWE Basic UDI-DI 16938535543314UDI-DIDate9 May 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  • Withdrawn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
Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel)
Model / Reference
Sterile Disposable Surgical Blade with Plastic Handle、Sterile Disposable Surgical Blade, No 13
Primary DI / UDI-DI
16938535543314
Basic UDI-DI
69385355SurgicalbladeCRWE
EMDN Code
V010302 Blades without safety systems, single-use - not included in other classes
Device Class
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000003351
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Huaiyin Medical Instruments Co., Ltd.

See all devices from Huaiyin Medical Instruments Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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