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Patient securement

by GRI Medical & Electronic Technology Co., Ltd. 20 variants

Ref PSKB100F

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69319181F050KY Basic UDI-DI 16931918118857UDI-DIDate2 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918118857 UDI-DI Date9 Feb 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Microtek
Generic Name
Freestanding patient positioner, single-use
Device Name
Patient securement
Model / Reference
PSKB100F EUDAMED
Model PSKB100F GUDID
Primary DI / UDI-DI
16931918118857
Basic UDI-DI
69319181F050KY
FDA Product Code
FMQ
EMDN Code
Z12011285 Patient positioning instruments - consumables
GMDN Term
Freestanding patient positioner, single-use
Device Class
Class I
Regulation Number
880.6760
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PSKB100F
GUDID
Model PSKB100F

Manufacturer details

EUDAMED SRN
CN-MF-000004203
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No