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T-Cuff® 71252

by Terumo BCT, Inc.

Ref 71252Model T-Cuff

T-Cuff® 71252 is a Class I device made by Terumo BCT, Inc., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 5020583TCuff3S), cleared under FDA 510(k) K162365 on 16 Feb 2017 and listed in FDA GUDID since 7 Jun 2021 (UDI-DI 05020583712522), active as of 8 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 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162365

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5020583TCuff3S Basic UDI-DI 05020583712522UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05020583712522 UDI-DI Date7 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162365 Date16 Feb 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5020583TCuff3S registered 3 Aug 2026 Active
  • FDA 510(k) K162365 decided 16 Feb 2017 Active
  • FDA GUDID UDI-DI 05020583712522 listed 7 Jun 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162365
  2. Listed FDA GUDID 05020583712522
  3. Registered EUDAMED 5020583TCuff3S

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  • Withdrawn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
T-Cuff®
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
71252, T-Cuff
Primary DI / UDI-DI
05020583712522
Basic UDI-DI
5020583TCuff3S
510(k) Number
FDA product code
KCY
EMDN code
Z12139006 Pneumatic tourniquets
GMDN term
Blood pressure cuff, reusable
Device class
Class I
Regulation number
878.5910
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 05020583712522: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Blood pressure cuff, reusable

Similar devices in this category

Other devices filed under PNEUMATIC TOURNIQUETS.

Other devices from Terumo BCT, Inc.

See all devices from Terumo BCT, Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)