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08033707067603

Extraoral device

Class IMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707067603
Basic UDI-DI: 080337070TDI002VH
Reference: M0771-00
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

08033707001379

DISTALIZER

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707001379
Basic UDI-DI: 080337070TDIIA001M04-8M
Reference: A1730-01
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

08033707000181

FIXED EXPANDER

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707000181
Basic UDI-DI: 080337070TDIIA001M03-8J
Reference: A0620-08
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

08033707000143

BITE

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707000143
Basic UDI-DI: 080337070TDIIA001M02-8F
Reference: A0595-10
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

08033707000006

EXPANSION SCREW

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707000006
Basic UDI-DI: 080337070TDIIA001M01-8C
Reference: A0515-14
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

Henry Schein

TF-291 (HS)

Class IMDR 2017/745On the marketSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: 10304040185916
Basic UDI-DI: 03040429101CT
Reference: 9009537
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

10195291009805

Extra-oral Headgear

Class IMDR 2017/745On the marketSingle use

Manufacturer: Flexmedics
Manufacturer SRN: US-MF-000013090
UDI-DI: 10195291009805
Basic UDI-DI: 0195291Headgear79
Reference: CPRB10
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

00192029042946

Instruments

Class IMDR 2017/745On the marketActive device

Manufacturer: TP Orthodontics, Inc.
Manufacturer SRN: US-MF-000020559
UDI-DI: 00192029042946
Basic UDI-DI: 0192029InstrumentsKB
Reference: 100-125
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 15.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

00192029041468

PreFinishers

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: TP Orthodontics, Inc.
Manufacturer SRN: US-MF-000020559
UDI-DI: 00192029041468
Basic UDI-DI: 0192029PreFinishers7H
Reference: 190-044
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 15.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

10190886134276

Orthodontic Hooks and Anchoring Auxiliaries

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: G&H Wire Company, Inc.
Manufacturer SRN: US-MF-000012129
UDI-DI: 10190886134276
Basic UDI-DI: 0190886AuxiliariesFG
Reference: SURHK
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: G&H Europe BV
Last updated: 15.07.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

10190886000243

Extra-oral Headgear

Class IMDR 2017/745On the marketSingle use

Manufacturer: G&H Wire Company, Inc.
Manufacturer SRN: US-MF-000012129
UDI-DI: 10190886000243
Basic UDI-DI: 0190886Headgear9Y
Reference: CP**10
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: G&H Europe BV
Last updated: 15.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Vero

Class IMDR 2017/745On the marketSingle use

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746202827
Basic UDI-DI: 01907460000234DV
Reference: 909-040815
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Spatula

Class IMDR 2017/745On the market

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746162305
Basic UDI-DI: 01907460000190E2
Reference: 010-008
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Tweezers

Class IMDR 2017/745On the market

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746162183
Basic UDI-DI: 01907460000192E6
Reference: 001-100M
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Power Pin

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746162121
Basic UDI-DI: 01907460000220DJ
Reference: 855-033122
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Luno Hand Instrument

Class IMDR 2017/745On the market

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746157165
Basic UDI-DI: 01907460000231DP
Reference: 001-027603
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Elastic Placer

Class IMDR 2017/745On the marketSingle use

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746153266
Basic UDI-DI: 01907460000198EJ
Reference: 909-035556
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Bracket Placement Guide

Class IMDR 2017/745On the market

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746153242
Basic UDI-DI: 01907460000183E5
Reference: 001-034934
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Arch Hook

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746146831
Basic UDI-DI: 01907460000205DN
Reference: 851-630CL
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Arch Stop

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: American Orthodontics
Manufacturer SRN: US-MF-000007702
UDI-DI: 00190746146701
Basic UDI-DI: 01907460000218DX
Reference: 851-611
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details