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sparrow swaddle™ - term infant size 0

by Little Sparrows Technologies, Inc.

Ref 0301A

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 linked in EUDAMED

A group certificate may exist

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 00810101280696UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810101280696 UDI-DI Date27 Jul 2026ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
sparrow swaddle - term infant size EUDAMED
sparrow swaddle™ - term infant size GUDID
Generic Name
Infant limb restraint, reusable
Device Name
Protective Restraint
Model / Ref / Catalog
0301A, 0
Primary DI / UDI-DI
00810101280696
Basic UDI-DI
081010128PRJQ
Direct Marketing DI
00810101280696
FDA Product Code
FMQ
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
GMDN Term
Infant limb restraint, reusable
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
0301A
GUDID
0

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Properties

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

Other properties (21)

  • Sterile: No
  • Single Use: 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