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Como

by B&L Biotech 10 variants

Part of a family of 10 devices: see the family page

Model COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4, VC2

Como is a dental material application tool (EU MDR Class I; FDA Class I; FDA product code KXR, Applicator, Resin) made by B&L Biotech, registered in EUDAMED on 17 Dec 2024 (Basic UDI-DI 88000191COMOLZ) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019111337), 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 Number88000191COMOLZ Basic UDI-DI 08800019111337UDI-DIDate17 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019111337 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191COMOLZ registered 17 Dec 2024 Active
  • FDA GUDID UDI-DI 08800019111337 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019111337
  2. Registered EUDAMED 88000191COMOLZ

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  • Withdrawn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
Como EUDAMED
COMO Tip GUDID
Generic name
Dental material application tool, reusable
Model / reference
COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4
Primary DI / UDI-DI
08800019111337
Basic UDI-DI
88000191COMOLZ, B-08800019111337
FDA product code
KXR
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental material application tool, reusable
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
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

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

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)