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Pomo

by B&L Biotech 3 variants

Model POMO, POMO W, POMO P, POMO

Pomo is a dental material heater (EU MDD Class I; FDA Class I; FDA product code KXR, Applicator, Resin) made by B&L Biotech, registered in EUDAMED on 27 Dec 2024 (Basic UDI-DI 88000191POMOPU) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019110651), active as of 22 Oct 2026.

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

CE MDR CE MDD

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/MDD EUDAMED Number88000191POMOPU Basic UDI-DI 08800019110651UDI-DIDate27 Dec 2024RegisteredStatusActive
European UnionCE/MDR EUDAMED Number88000191POMOPU Basic UDI-DI 08800019110651UDI-DIDate27 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019110651 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191POMOPU registered 27 Dec 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800019110651 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019110651
  2. Registered EUDAMED 88000191POMOPU

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pomo EUDAMED
POMO Black GUDID
Generic name
Dental material heater
Model / reference
POMO EUDAMED
POMO W EUDAMED
POMO P EUDAMED
POMB GUDID
Primary DI / UDI-DI
08800019110651
Basic UDI-DI
88000191POMOPU, B-08800019110651
FDA product code
KXR
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental material heater
Device class
Class I
Regulation number
872.3140
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
POMO, POMO W, POMO P
none
POMO
GUDID
POMB

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)