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Primedge

by Huaian Tianda Medical Instruments Co., Ltd. China EUDAMED

Ref 0722Model 9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36

EMDN V010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69519338SBGV Basic UDI-DIDate6 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Surgical Blades
Model / Reference
9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36, 0722
Primary DI / UDI-DI
06951933811222
Basic UDI-DI
69519338SBGV
EMDN Code
V010302 Blades without safety systems, single-use - not included in other classes
Device Class
Class IIa
Market of Registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000031504
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Related devices

Category: Scalpel, single-use

Other devices from Huaian Tianda Medical Instruments Co., Ltd.

See all devices from Huaian Tianda Medical Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED f2d831cb-ec16-4737-a41c-4b7b730c658a 61 fields · synced 24 Oct 2026