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HAT 1 Scanning Kit

by Ziyang Freqty Medical Equipment Co., Ltd. 60 variants

Ref PKA-28Model HAT 1 Scanbody: PS-01~07; HAT 1 Lab Analog: PA-01~02; HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07; HAT 1 Scanning Kit: PKA-01~27

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697513623PTHAT1RS Basic UDI-DI 06975136231281UDI-DIDate18 Jul 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  • Withdrawn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
Dental implant accessories
Model / Reference
HAT 1 Scanbody: PS-01~07, HAT 1 Lab Analog: PA-01~02, HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07, HAT 1 Scanning Kit: PKA-01~27, PKA-28
Primary DI / UDI-DI
06975136231281
Basic UDI-DI
697513623PTHAT1RS
EMDN Code
P01020180 Dental implants - accessories
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000019421
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ziyang Freqty Medical Equipment Co., Ltd.

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Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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