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LotFancy 11C-1827-G

by Honsun (Nantong) Co., Ltd

Ref HS-401F8

LotFancy 11C-1827-G is a device classified as Class I in the EU and Class II in the US made by Honsun (Nantong) Co., Ltd, registered in EUDAMED on 11 Feb 2022 (Basic UDI-DI 697038425PLTTC), cleared under FDA 510(k) K092245 on 28 Oct 2009 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 06970384250503), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092245

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697038425PLTTC Basic UDI-DI 06970384250503UDI-DIDate11 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06970384250503 UDI-DI Date18 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK092245 Date28 Oct 2009IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697038425PLTTC registered 11 Feb 2022 Active
  • FDA 510(k) K092245 decided 28 Oct 2009 Active
  • FDA GUDID UDI-DI 06970384250503 listed 18 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092245
  2. Listed FDA GUDID 06970384250503
  3. Registered EUDAMED 697038425PLTTC

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  • Withdrawn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
penlight EUDAMED
LotFancy GUDID
Generic name
Aneroid manual sphygmomanometer
Model / reference
HS-401F8 EUDAMED
11C-1827-G GUDID
Primary DI / UDI-DI
06970384250503
Basic UDI-DI
697038425PLTTC
510(k) Number
FDA product code
DXQ
EMDN code
Q0399 ENT devices - other
GMDN term
Aneroid manual sphygmomanometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1120
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
HS-401F8
GUDID
11C-1827-G
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: Aneroid manual sphygmomanometer

Cleared under the same submission (K092245)

and 8 more cleared under K092245

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

Other devices from Honsun (Nantong) Co., Ltd

See all devices from Honsun (Nantong) Co., Ltd →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (23, all answered No)