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Neonatal Heat Loss Prevention Suit Small/Medium/Large

by Poly Medicure Limited 3 variants

Ref 44008Model Neonatal Heat Loss Prevention Suit Small/Medium/Large

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 linked in EUDAMED

A group certificate may exist

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 Number890209544006F7 Basic UDI-DI 08902095440087UDI-DIDate14 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Neonatal Heat Loss Prevention Suit Small/Medium/Large, 44008
Primary DI / UDI-DI
08902095440087
Basic UDI-DI
890209544006F7
EMDN Code
V028099 Neonatology and pediatrics devices - accessories not included in other classes - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000003380
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Poly Medicure Limited

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Properties

  • Sterile

Other properties (12)

  • 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