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Access Pure M1

by Ineocare Spółka Z Ograniczoną Odpowiedzialnością 6 variants

Ref A817247C20, A817250C00, A817249C20, A817248C20, A817252C20, A817248C00, A817250C20, A817245C20, A817251C20, A817252C00, A817245C00, PW1.0033.5**, PWA.1410.5**, PD1.0051.5**, PD0.0081.5**, PD2.0002.5**, PD0.0008.5**, PLA.0631.5**, PD0.0009.5**, PW1.0044.5**, PW1.0048.5**, PD0.0010.5**, PD0.0011.5**, PW0.0003.5**

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590389990ROCAQR Basic UDI-DI Date27 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
Access Pure M1
Pure
Device Name
Pomoce Dla Niepełnosprawnych
Model / Reference
A817247C20, A817250C00, A817249C20, A817248C20, A817252C20, A817248C00, A817250C20, A817245C20, A817251C20, A817252C00, A817245C00, PW1.0033.5**, PWA.1410.5**, PD1.0051.5**, PD0.0081.5**, PD2.0002.5**, PD0.0008.5**, PLA.0631.5**, PD0.0009.5**, PW1.0044.5**, PW1.0048.5**, PD0.0010.5**, PD0.0011.5**, PW0.0003.5**
Primary DI / UDI-DI
05903899903207, 05903899903252, 05903899903245, 05903899903221, 05903899903306, 05903899903214, 05903899903269, 05903899903160, 05903899903283, 05903899903290, 05903899903153, 05903899903412, 05903899903566, 05903899903467, 05903899903528, 05903899903535, 05903899903481, 05903899903399, 05903899903498, 05903899903429, 05903899903443, 05903899903504, 05903899903511, 05903899903313
Basic UDI-DI
590389990ROCAQR, 590389990PURESW
Direct Marketing DI
05903899903207
05903899903252
05903899903245
05903899903221
05903899903306
05903899903214
05903899903269
05903899903160
05903899903283
05903899903290
05903899903153
05903899903412
05903899903566
05903899903467
05903899903528
05903899903535
05903899903481
05903899903399
05903899903498
05903899903429
05903899903443
05903899903504
05903899903511
05903899903313
EMDN Code
V0899 Medical support equipment - other
Device Class
Class I
EU market of registration
Spain
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000034645

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No