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Fdk Bt-A11CN

by Fudakang Industrial Inc.

Ref BT-A11CN

Fdk Bt-A11CN is a device classified as Class IIa in the EU and Class II in the US made by Fudakang Industrial Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-06955647600011), cleared under FDA 510(k) K101387 on 3 Aug 2010 and listed in FDA GUDID since 15 Sep 2020 (UDI-DI 06955647600011), active as of 7 Nov 2026.

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

CE MDD 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) K101387

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/MDD EUDAMED NumberB-06955647600011 Basic UDI-DI 06955647600011UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06955647600011 UDI-DI Date15 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101387 Date3 Aug 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06955647600011 registered 4 Nov 2026 Active
  • FDA 510(k) K101387 decided 3 Aug 2010 Active
  • FDA GUDID UDI-DI 06955647600011 listed 15 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101387
  2. Listed FDA GUDID 06955647600011
  3. Registered EUDAMED B-06955647600011

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Electronic Clinical Thermometer EUDAMED
Fdk GUDID
Generic name
General-purpose patient temperature probe, single-use
Model / reference
BT-A11CN
Primary DI / UDI-DI
06955647600011
Basic UDI-DI
B-06955647600011
510(k) Number
FDA product code
FLL
EMDN code
V0301010201 Contact digital thermometers (including probes)
GMDN term
General-purpose patient temperature probe, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.2910
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: General-purpose patient temperature probe, single-use

Cleared under the same submission (K101387)

and 8 more cleared under K101387

Similar devices in this category

Other devices filed under CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES).

Other devices from Fudakang Industrial Inc.

  • Fdk Bt-A13

    Class II

  • Fdk Bt-A21CN

    Class II

  • Fdk Bt-A31CN

    Class II

  • Fdk Ft-F33

    Class II

See all devices from Fudakang Industrial Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)