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JETIP Instruments

by B&L Biotech 44 variants

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

Model 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 is a dental mirror (EU MDR Class I; FDA Class I; FDA product code EAX, Mirror, Mouth) made by B&L Biotech, registered in EUDAMED on 9 Oct 2024 (Basic UDI-DI 88000191JINSTL5) and listed in FDA GUDID since 19 Dec 2024 (UDI-DI 08800019115038), 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
United StatesGUDID listing GUDID Number08800019115038 UDI-DI Date19 Dec 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000191JINSTL5 Basic UDI-DI 08800019115038UDI-DIDate9 Oct 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191JINSTL5 registered 9 Oct 2024 Active
  • FDA GUDID UDI-DI 08800019115038 listed 19 Dec 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 88000191JINSTL5
  2. Listed FDA GUDID 08800019115038

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  • Withdrawn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
JETIP Instruments EUDAMED
B&L Mirror GUDID
Generic name
Dental mirror, reusable
Model / reference
JEX EUDAMED
JE1 EUDAMED
JC4 EUDAMED
JC3 EUDAMED
JC9 EUDAMED
JX2 EUDAMED
JE2 EUDAMED
JE4 EUDAMED
JC1 EUDAMED
JX1 EUDAMED
JPP EUDAMED
JC2 EUDAMED
JE3 EUDAMED
JC12 EUDAMED
JM3 EUDAMED
JC10 EUDAMED
JM2 EUDAMED
JC13 EUDAMED
JC16 EUDAMED
JC15 EUDAMED
JC11 EUDAMED
JM1 EUDAMED
JM4 EUDAMED
JC14 EUDAMED
JP6 EUDAMED
JP2 EUDAMED
JP8 EUDAMED
JP7 EUDAMED
JB2 EUDAMED
JP3 EUDAMED
JP9 EUDAMED
JIHB EUDAMED
JIHY EUDAMED
JIHS EUDAMED
TJIHS EUDAMED
JIHG EUDAMED
TJIHY EUDAMED
TJIHB EUDAMED
TJIHG EUDAMED
JX5 GUDID
Primary DI / UDI-DI
08800019115038
Basic UDI-DI
88000191JINSTL5
FDA product code
EAX
EMDN code
L160201 Dental mirrors and handles, reusable
GMDN term
Dental mirror, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
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

Similar devices in this category

Other devices filed under DENTAL MIRRORS AND HANDLES, REUSABLE.

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Properties

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