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Alternating Pressure Redistribution System

by Wellell Inc.

Part of a family of 7 devices: see the family page

Ref 9M052005

Alternating Pressure Redistribution System (9M052005) is a Class I device made by Wellell Inc., registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI 302500pmattressI019B), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number302500pmattressI019B Basic UDI-DI 04719893357233UDI-DIDate29 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Alternating Pressure Redistribution System
Model / reference
9M052005
Primary DI / UDI-DI
04719893357233
Basic UDI-DI
302500pmattressI019B
EMDN code
V080701 Active anti-decubitus medical mattresses
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000009159
Authorised representative
Wellell Iberia S.L. ES-AR-000003668

Similar devices in this category

Other devices filed under ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES.

Other devices from Wellell Inc.

See all devices from Wellell Inc. →

Properties

Other properties (14, all answered No)