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Pacee Pacifier 15A

by Small Beginnings, Inc.

Ref 15A

Pacee Pacifier 15A is a Class I device made by Small Beginnings, Inc., registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 081509001PACIFIERCU) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 00815090010026), 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
European UnionCE/MDR EUDAMED Number081509001PACIFIERCU Basic UDI-DI 00815090010026UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00815090010026 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081509001PACIFIERCU registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00815090010026 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00815090010026
  2. Registered EUDAMED 081509001PACIFIERCU

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  • Withdrawn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
Pacee EUDAMED
Pacee Pacifier GUDID
Generic name
Infant oral pacifier
Model / Ref / Catalog
15A
Primary DI / UDI-DI
00815090010026
Basic UDI-DI
081509001PACIFIERCU
FDA product code
MEF
EMDN code
V028099 Neonatology and pediatrics devices - accessories not included in other classes - other
GMDN term
Infant oral pacifier
Device class
Class I
Regulation number
872.5550
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infant oral pacifier

Similar devices

Also classified as Infant oral pacifier.

Similar devices in this category

Other devices filed under NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Small Beginnings, Inc.

See all devices from Small Beginnings, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)