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JETIP Instruments

by B&L Biotech 44 variants

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

Model JIBH, 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 (JIBH) is a scalpel handle (EU MDR Class I; FDA Class I; FDA product code EMJ, Elevator, Surgical, Dental) made by B&L Biotech, registered in EUDAMED on 26 Dec 2024 (Basic UDI-DI B-08800019115489) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019115489), 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/MDR EUDAMED NumberB-08800019115489 Basic UDI-DI 08800019115489UDI-DIDate26 Dec 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800019115489 Basic UDI-DI 08800019115489UDI-DIDate26 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019115489 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800019115489 registered 26 Dec 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800019115489 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019115489
  2. Registered EUDAMED B-08800019115489

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
JETIP Instruments EUDAMED
Blade Handle GUDID
Generic name
Scalpel handle, reusable
Model / reference
JIBH, 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
Primary DI / UDI-DI
08800019115489
Basic UDI-DI
B-08800019115489, 88000191JINSTL5
FDA product code
EMJ
EMDN code
Q0199 Odontology devices - other
GMDN term
Scalpel handle, 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)