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Applanation Tonometer

by Shanghai Mediworks Precision Instruments Co., Ltd. 2 variants

Ref T170Model T170,TAT-80R

Applanation Tonometer (T170) is an ophthalmic tonometer (EU MDR Class IIa; FDA Class II; FDA product code HKY, Tonometer, Manual) made by Shanghai Mediworks Precision Instruments Co., Ltd., registered in EUDAMED on 21 Apr 2023 (Basic UDI-DI 69450875TonometersV5), cleared under FDA 510(k) K142263 on 15 Apr 2016 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 06945087517017), 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) K142263

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 Number69450875TonometersV5 Basic UDI-DI 06945087517017UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945087517017 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK142263 Date15 Apr 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69450875TonometersV5 registered 21 Apr 2023 Active
  • FDA 510(k) K142263 decided 15 Apr 2016 Active
  • FDA GUDID UDI-DI 06945087517017 listed 1 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142263
  2. Listed FDA GUDID 06945087517017
  3. Registered EUDAMED 69450875TonometersV5

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  • Withdrawn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
Applanation Tonometer EUDAMED
MediWorks GUDID
Generic name
Ophthalmic tonometer, manual
Model / reference
T170 EUDAMED
TAT-80R EUDAMED
T170(R) GUDID
Primary DI / UDI-DI
06945087517017
Basic UDI-DI
69450875TonometersV5
Direct marketing DI
06945087517017
510(k) Number
FDA product code
HKY
EMDN code
Z12120122 Tonometers
GMDN term
Ophthalmic tonometer, manual
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1930
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
T170,TAT-80R
T170
GUDID
T170(R)
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000004251
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under TONOMETERS.

Other devices from Shanghai Mediworks Precision Instruments Co., Ltd.

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Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)