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Primedge

by Huaian Tianda Medical Instruments Co., Ltd. 27 variants

Ref 0720Model 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

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 Number69519338SBGV Basic UDI-DI 06951933811208UDI-DIDate6 Nov 2025RegisteredStatusActive

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  • Withdrawn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
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, 0720
Primary DI / UDI-DI
06951933811208
Basic UDI-DI
69519338SBGV
EMDN Code
V010302 Blades without safety systems, single-use - not included in other classes
Device Class
Class IIa
EU 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

  • 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