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AllPEP

by Enchant Tek Co., Ltd.

Ref EN-PEP-100

AllPEP (EN-PEP-100) is a medical device (EU MDR Class IIa; EMDN category respiratory and anaesthesia devices) made by Enchant Tek. Co, Ltd., registered in EUDAMED on 15 May 2025 (Basic UDI-DI 471988230ENPEP010211HH) and cleared under FDA 510(k) K233855 on 2 Feb 2024, active as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233855↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471988230ENPEP010211HH Basic UDI-DI 04719882300219UDI-DIDate15 May 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK233855 Date2 Feb 2024IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 471988230ENPEP010211HH registered 15 May 2025 Active
  • FDA 510(k) K233855 decided 2 Feb 2024 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K233855
  2. Registered EUDAMED 471988230ENPEP010211HH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
Oscillating Positive Expiratory Pressure
Model / reference
EN-PEP-100
Primary DI / UDI-DI
04719882300219
Basic UDI-DI
471988230ENPEP010211HH
EMDN code
R9099 Respiratory and anaesthesia devices - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000037003
Authorised representative
Wellell Iberia S.L. ES-AR-000003668

Related devices

Category: Pulmonary function analysis system, adult

Similar devices in this category

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  • AllNEB

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Properties

Other properties (14, all answered No)