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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Amalgam Spatel m.Silber Enden

Spatel, Zement

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Zepf Medical Instruments GmbH
Manufacturer SRN: DE-MF-000005528
UDI-DI: 04250379940896
Basic UDI-DI: 4250485300000135ZD
Reference: 84-1801-02
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:07

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SPARK Retainers – Refinement

728-4*

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Ormco Corporation
Manufacturer SRN: US-MF-000038085
UDI-DI: 00889989089042
Basic UDI-DI: 0889989-Sprk_Retainer-EF
Reference: 728-4022
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: KERR ITALIA SRL
Last updated: 16.07.2026 07:50

Manufacturer products Authorised representative products Authorised representative actors View details

SPARK 10 - DUAL ARCH

728-*

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Ormco Corporation
Manufacturer SRN: US-MF-000038085
UDI-DI: 00889989083446
Basic UDI-DI: 0889989-Sprk_Clr_Align-48
Reference: 728-3010
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: KERR ITALIA SRL
Last updated: 16.07.2026 07:50

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HEX KEY .050 FOR SCREWS PK2 - ADVANSYNC 2

600-42*

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ormco Corporation
Manufacturer SRN: US-MF-000038085
UDI-DI: 00889989054682
Basic UDI-DI: 0889989-AdSync2_HexKey-Y4
Reference: 600-4290
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Italy
Authorised representative: KERR ITALIA SRL
Last updated: 16.07.2026 07:49

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00885797883544

Orthodontic Multi-Family Appliances

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: RMO
Manufacturer SRN: US-MF-000034842
UDI-DI: 00885797883544
Basic UDI-DI: 0885797MultiRN
Reference: XPWHL35
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: France
Authorised representative: RMO EUROPE
Last updated: 16.07.2026 07:24

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Gishy Goo

Class IMDR 2017/745On the market

Manufacturer: Ultradent Products, Inc.
Manufacturer SRN: US-MF-000013697
UDI-DI: 00883205106537
Basic UDI-DI: 0883205-TF254BC
Reference: 2749
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: Ultradent Products GmbH
Last updated: 16.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

Platypus

Aligner Seating Chew

Class IMDR 2017/745On the marketSingle use

Manufacturer: Glenroe, LLC
Manufacturer SRN: US-MF-000056655
UDI-DI: 00858813002175
Basic UDI-DI: 08588130020200P4
Reference: AC150
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

Oral Protector

Reusable Oral Protector EMGD

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007041
Basic UDI-DI: 08502980070497
Reference: EMGD
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Gishy Goo

Class IMDR 2017/745On the market

Manufacturer: Ultradent Products, Inc.
Manufacturer SRN: US-MF-000013697
UDI-DI: 00883205107312
Basic UDI-DI: 0883205-TF254BC
Reference: 500059
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: -
Authorised representative: Ultradent Products GmbH
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura TRAK

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682406
Basic UDI-DI: 08500166820004G9
Reference: 9308
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura FLX and Zendura VIVA

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682147
Basic UDI-DI: 08500166820003G7
Reference: 9204-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura AT

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682116
Basic UDI-DI: 08500166820002G5
Reference: 9206-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zendura

Zendura A

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bay Materials LLC
Manufacturer SRN: US-MF-000049150
UDI-DI: 00850016682031
Basic UDI-DI: 08500166820001G3
Reference: 9156-20
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

00850032808507

Orthodontic Wax

Class IMDR 2017/745On the marketSingle use

Manufacturer: O&S Dental, Inc.
Manufacturer SRN: US-MF-000023206
UDI-DI: 00850032808507
Basic UDI-DI: 081744102TF085K
Reference: 370-000
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Belgium
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:34

Manufacturer products Authorised representative products Authorised representative actors View details

Invisalign Specifix Attachment System

Class IIaMDR 2017/745On the market

Manufacturer: Align Technology Inc.
Manufacturer SRN: US-MF-000000744
UDI-DI: 00816063023777
Basic UDI-DI: 081606302Specifix8W
Reference: 5036
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

Invisalign Palatal Holder

Invisalign Palatal Expander System

Class IIaMDR 2017/745On the market

Manufacturer: Align Technology Inc.
Manufacturer SRN: US-MF-000000744
UDI-DI: 00816063021384
Basic UDI-DI: 081606302IPESystem6S
Reference: 9032
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

Invisalign Cheek Retractor, Medium

Class IMDR 2017/745On the market

Manufacturer: Align Technology Inc.
Manufacturer SRN: US-MF-000000744
UDI-DI: 00816063021131
Basic UDI-DI: 081606302CheekRetR8
Reference: 202430
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

Invisalign Full

Invisalign System

Class IIaMDR 2017/745On the market

Manufacturer: Align Technology Inc.
Manufacturer SRN: US-MF-000000744
UDI-DI: 00816063020004
Basic UDI-DI: 081606302InvisalignMH
Reference: 8500
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

08033707088158

Thermoplastic and Thermoforming material

Class IMDR 2017/745On the marketSingle use

Manufacturer: LEONE S.P.A.
Manufacturer SRN: IT-MF-000005986
UDI-DI: 08033707088158
Basic UDI-DI: 080337070TDI001VF
Reference: R7001-05
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

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