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MedibinoNEO disposable cover cotton knit WITH soft granules - colour coded - Size M - unit of use

by Kluba Medical GmbH

Ref PCMN0014, 31021703-MModel Sizes S-L

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260764840830 UDI-DI Date6 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4260764840002XQ Basic UDI-DI Date2 Jan 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MedibinoNEO disposable cover cotton knit WITH soft granules - colour coded - Size M - unit of use EUDAMED
MedibinoNEO disposable cover cotton knit WITH soft granules - colour coded - Size M - PU 50 EUDAMED
MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50 GUDID
Generic Name
Infant recumbent sleep positioner
Device Name
MedibinoNEO ring in different sizes with accessories in different sizes
Model / Ref / Catalog
Sizes S-L, PCMN0014, 31021703-M, 1
Primary DI / UDI-DI
04260764840830, 04260764840687
Basic UDI-DI
4260764840002XQ
Direct Marketing DI
04260764840830
04260764840687
FDA Product Code
PRN, FRP, FMP
EMDN Code
V028099 Neonatology and pediatrics devices - accessories not included in other classes - other
GMDN Term
Infant recumbent sleep positioner
Device Class
Class I
Regulation Number
880.5680, 880.6450
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Sizes S-L
PCMN0014
31021703-M
GUDID
1

Manufacturer details

EUDAMED SRN
DE-MF-000005421

Other devices from Kluba Medical GmbH

See all devices from Kluba Medical GmbH →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No