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AnsCare SIMO NP-2-4

by Benq Materials Corp.

Ref NP-2-4

AnsCare SIMO NP-2-4 is a negative-pressure wound therapy system pump (EU MDD Class IIb; FDA Class II; FDA product code OKO, Negative Pressure Wound Therapy Non-Powered Suction Apparatus) made by Benq Materials Corp., registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-04719745008221), cleared under FDA 510(k) K193185 on 4 May 2020 and listed in FDA GUDID since 9 Feb 2021 (UDI-DI 04719745008221), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193185

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/MDD EUDAMED NumberB-04719745008221 Basic UDI-DI 04719745008221UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719745008221 UDI-DI Date9 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193185 Date4 May 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04719745008221 registered 15 Oct 2026 Active
  • FDA 510(k) K193185 decided 4 May 2020 Active
  • FDA GUDID UDI-DI 04719745008221 listed 9 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193185
  2. Listed FDA GUDID 04719745008221
  3. Registered EUDAMED B-04719745008221

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  • Withdrawn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
Anscare EUDAMED
AnsCare SIMO GUDID
Generic name
Negative-pressure wound therapy system pump, mechanical
Model / reference
NP-2-4
Primary DI / UDI-DI
04719745008221
Basic UDI-DI
B-04719745008221
510(k) Number
FDA product code
OKO
EMDN code
M040499 Dressings for wounds, sores and ulcerations - other
GMDN term
Negative-pressure wound therapy system pump, mechanical
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4683
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Negative-pressure wound therapy system pump, mechanical

Cleared under the same submission (K193185)

and 7 more cleared under K193185

Similar devices in this category

Other devices filed under DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER.

Other devices from Benq Materials Corp.

See all devices from Benq Materials Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)