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Micro Shaper

by Shanwei Perfect Medical Instruments Co., Ltd. 19 variants

Ref 08/.03、10/.03、15/.02、Model H Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02. K Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02, 010 04,010 06,015 04. F Shaper: 015 05,020 05,025 05,030 05

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69422009MicroShaper59 Basic UDI-DI 06942200938674UDI-DIDate8 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental File (Micro Shaper）
Model / Reference
H Shaper: 008 03, 010 03, 015 02, 020 02, 025 02, 030 02, 035 02, 040 02. K Shaper: 008 03, 040 02, 010 04, 010 06, 015 04. F Shaper: 015 05, 020 05, 025 05, 030 05, 08/.03、10/.03、15/.02、
Primary DI / UDI-DI
06942200938674
Basic UDI-DI
69422009MicroShaper59
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanwei Perfect Medical Instruments Co., Ltd.

See all devices from Shanwei Perfect Medical Instruments 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