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feather swaddle™ 0

by Little Sparrows Technologies, Inc.

Ref 0401A

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081010128PRJQ Basic UDI-DI 00810101280702UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810101280702 UDI-DI Date27 Jul 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
feather swaddle EUDAMED
feather swaddle™ GUDID
Generic Name
Infant limb restraint, single-use
Device Name
Protective Restraint
Model / Ref / Catalog
0401A, 0
Primary DI / UDI-DI
00810101280702
Basic UDI-DI
081010128PRJQ
Direct Marketing DI
00810101280702
FDA Product Code
FMQ
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
GMDN Term
Infant limb restraint, single-use
Device Class
Class I
Regulation Number
880.6760
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0401A
GUDID
0

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No