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Med-Link W0001B

by Shenzhen Med-Link Electronics Tech Co., Ltd.

Ref Y000DSN2-4#Model Y000DA1

Med-Link W0001B is a device classified as Class I in the EU and Class II in the US made by Shenzhen Med-Link Electronics Tech Co., Ltd., registered in EUDAMED on 9 May 2024 (Basic UDI-DI 69444140007SS), cleared under FDA 510(k) K182667 on 18 Jun 2019 and listed in FDA GUDID since 20 Dec 2022 (UDI-DI 06944414050005), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182667

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444140007SS Basic UDI-DI 06944414050005UDI-DIDate9 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06944414050005 UDI-DI Date20 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK182667 Date18 Jun 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69444140007SS registered 9 May 2024 Active
  • FDA 510(k) K182667 decided 18 Jun 2019 Active
  • FDA GUDID UDI-DI 06944414050005 listed 20 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182667
  2. Listed FDA GUDID 06944414050005
  3. Registered EUDAMED 69444140007SS

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  • Withdrawn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
NIBP cuff and accessories EUDAMED
Med-Link GUDID
Generic name
General-purpose patient temperature probe, reusable
Model / reference
Y000DA1 EUDAMED
Y000DSN2-4# EUDAMED
W0001B GUDID
Primary DI / UDI-DI
06944414050005
Basic UDI-DI
69444140007SS
510(k) Number
FDA product code
FLL
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
General-purpose patient temperature probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.2910
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Y000DA1
Y000DSN2-4#
GUDID
W0001B
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: General-purpose patient temperature probe, reusable

Similar devices in this category

Other devices filed under NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from Shenzhen Med-Link Electronics Tech Co., Ltd.

See all devices from Shenzhen Med-Link Electronics Tech Co., Ltd. →

Properties

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