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Positioning Cap Lycra-10-20

by Shenzhen Yingzhi Technology Co., Ltd.

Ref 02-00-08、02-00-09、02-00-10, 02-00-02、02-00-05、02-00-06Model Lycra-10-20

Positioning Cap Lycra-10-20 is a Class I device made by Shenzhen Yingzhi Technology Co., Ltd., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 69715385802XW), cleared under FDA 510(k) K230735 on 13 Sep 2023 and listed in FDA GUDID since 21 Dec 2023 (UDI-DI 06971538580286), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230735

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69715385802XW Basic UDI-DI 06971538580286UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971538580286 UDI-DI Date21 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230735 Date13 Sep 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69715385802XW registered 19 Oct 2026 Active
  • FDA 510(k) K230735 decided 13 Sep 2023 Active
  • FDA GUDID UDI-DI 06971538580286 listed 21 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230735
  2. Listed FDA GUDID 06971538580286
  3. Registered EUDAMED 69715385802XW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
YINGCHI Positioning Cap EUDAMED
Positioning Cap GUDID
Generic name
Head marking cap
Model / reference
Lycra-10-20, 02-00-08、02-00-09、02-00-10, 02-00-02、02-00-05、02-00-06
Primary DI / UDI-DI
06971538580286
Basic UDI-DI
69715385802XW, 69715385810-202Q
Direct marketing DI
06971538580286
510(k) Number
FDA product code
FYF
EMDN code
N018099 Encephalic and peripheral nervous system devices - accessories - other
GMDN term
Head marking cap
Device class
Class I
Regulation number
878.4040
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Related devices

Category: Head marking cap

Cleared under the same submission (K230735)

and 8 more cleared under K230735

Similar devices in this category

Other devices filed under ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER.

Other devices from Shenzhen Yingzhi Technology Co., Ltd.

See all devices from Shenzhen Yingzhi Technology Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)