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bili-ruler

by Little Sparrows Technologies, Inc.

Ref 0203A

bili-ruler (0203A) is a transcutaneous bilirubinometer (EU MDR Class I; FDA Class I; FDA product code HIT, Tester, Color Vision) made by Little Sparrows Technologies, Inc., registered in EUDAMED on 18 Mar 2025 (Basic UDI-DI 0810101280203JJ) and listed in FDA GUDID since 7 Apr 2026 (UDI-DI 00810101280498), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810101280498 UDI-DI Date7 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0810101280203JJ Basic UDI-DI 00810101280498UDI-DIDate18 Mar 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0810101280203JJ registered 18 Mar 2025 Active
  • FDA GUDID UDI-DI 00810101280498 listed 7 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0810101280203JJ
  2. Listed FDA GUDID 00810101280498

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  • Withdrawn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

Generic name
Transcutaneous bilirubinometer
Model / Ref / Catalog
0203A, 0
Primary DI / UDI-DI
00810101280498
Basic UDI-DI
0810101280203JJ
Direct marketing DI
00810101280498
FDA product code
HIT
EMDN code
Z12080499 Neonatology instruments - other
GMDN term
Transcutaneous bilirubinometer
Device class
Class I
Regulation number
886.1170
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0203A
GUDID
0

Manufacturer details

EUDAMED SRN
US-MF-000040265
Authorised representative
CEpartner4U NL-AR-000000111

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Other devices filed under NEONATOLOGY INSTRUMENTS.

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)