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Puhla

by Puhla Oy 15 variants

Ref 2042-LMU-XL, 2041-LMU-L, 2041-HRM-S, 2041-LMU-M, 2042-HRM-S, 2041-HRM-L, 2041-HRM-XL, 2041-LMU-XS, 2042-HRM-M, 2041-SNN-XL, 2042-HRM-XL, 8050, 2042-SNN-M, 2041-LMU-S, 2042-LMU-M, 2042-LMU-L, 2041-SNN-XSModel 2041

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643007415phlwearhygKP Basic UDI-DI Date19 Sep 2024RegisteredStatusActive

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  • Withdrawn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
Hygiene coverall
Walking belt
Model / Reference
2041, 2042-LMU-XL, 2041-LMU-L, 2041-HRM-S, 2041-LMU-M, 2042-HRM-S, 2041-HRM-L, 2041-HRM-XL, 2041-LMU-XS, 2042-HRM-M, 2041-SNN-XL, 2042-HRM-XL, 8050, 2042-SNN-M, 2041-LMU-S, 2042-LMU-M, 2042-LMU-L, 2041-SNN-XS
Primary DI / UDI-DI
06430074151218, 06430074151348, 06430074151317, 06430074151355, 06430074151157, 06430074151294, 06430074151324, 06430074151386, 06430074151140, 06430074151423, 06430074151164, 06430074151713, 06430074151249, 06430074151362, 06430074151195, 06430074151188, 06430074151485, 06430074151430
Basic UDI-DI
643007415phlwearhygKP, 643007415phlassist8050SQ
EMDN Code
T0299, Y99
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000042691

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