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JETIP Instruments

by B&L Biotech 44 variants

Part of a family of 44 devices: see the family page

Model JB2, JEX, JE1, JC4, JC3, JC9, JX2, JE2, JE4, JC1, JX1, JPP, JC2, JE3, JC12, JM3, JC10, JM2, JC13, JC16, JC15, JC11, JM1, JM4, JC14, JP6, JP2, JP8, JP7, JB2, JP3, JP9, JIHB, JIHY, JIHS, TJIHS, JIHG, TJIHY, TJIHB, TJIHG

JETIP Instruments (JB2) is a dental material application tool (EU MDD Class I; FDA Class I; FDA product code EMJ, Elevator, Surgical, Dental) made by B&L Biotech, registered in EUDAMED on 24 May 2024 (Basic UDI-DI B-08800019115328) and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 08800019115328), active as of 22 Oct 2026.

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

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 NumberB-08800019115328 Basic UDI-DI 08800019115328UDI-DIDate24 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019115328 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800019115328 registered 24 May 2024 Active
  • FDA GUDID UDI-DI 08800019115328 listed 6 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019115328
  2. Registered EUDAMED B-08800019115328

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental material application tool, reusable
Model / reference
JB2, JEX, JE1, JC4, JC3, JC9, JX2, JE2, JE4, JC1, JX1, JPP, JC2, JE3, JC12, JM3, JC10, JM2, JC13, JC16, JC15, JC11, JM1, JM4, JC14, JP6, JP2, JP8, JP7, JP3, JP9, JIHB, JIHY, JIHS, TJIHS, JIHG, TJIHY, TJIHB, TJIHG
Primary DI / UDI-DI
08800019115328
Basic UDI-DI
B-08800019115328, 88000191JINSTL5
FDA product code
EMJ
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental material application tool, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
Standard device
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

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Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)