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Tbl-Abi C001

by LD Technology

Ref C001

Tbl-Abi C001 is a device classified as Class IIa in the EU and Class II in the US made by LD Technology, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08600135619TBLQE), cleared under FDA 510(k) K173696 on 19 Dec 2017 and listed in FDA GUDID since 16 Jan 2019 (UDI-DI 00860013561925), 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) K173696

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 Number08600135619TBLQE Basic UDI-DI 00860013561925UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860013561925 UDI-DI Date16 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK173696 Date19 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08600135619TBLQE registered 26 Oct 2026 Active
  • FDA 510(k) K173696 decided 19 Dec 2017 Active
  • FDA GUDID UDI-DI 00860013561925 listed 16 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173696
  2. Listed FDA GUDID 00860013561925
  3. Registered EUDAMED 08600135619TBLQE

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  • Withdrawn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
LD Technology EUDAMED
Tbl-Abi GUDID
Generic name
Manual-inflation electronic sphygmomanometer, non-portable
Model / reference
C001
Primary DI / UDI-DI
00860013561925 EUDAMED
B322C0011 GUDID
Basic UDI-DI
08600135619TBLQE
510(k) Number
FDA product code
JOM
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
Manual-inflation electronic sphygmomanometer, non-portable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2780
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00860013561925
GUDID
B322C0011
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00860013561925; FDA GUDID lists B322C0011), so their flags are not compared. 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.

From the manufacturer

Manufacturer's product page: ANKLE BRACHIAL INDEX / TBL-ABI MODEL C001

Related devices

Category: Manual-inflation electronic sphygmomanometer, non-portable

Similar devices in this category

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

Other devices from LD Technology

See all devices from LD Technology →

Properties

  • Measuring function
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)