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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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OraSeal Kit

Class IMDR 2017/745On the market

Manufacturer: Ultradent Products, Inc.
Manufacturer SRN: US-MF-000013697
UDI-DI: 00883205103482
Basic UDI-DI: 0883205-TF049B9
Reference: 352
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: -
Authorised representative: Ultradent Products GmbH
Last updated: 16.07.2026 06:17

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OraSeal Caulking Refill

Class IMDR 2017/745On the market

Manufacturer: Ultradent Products, Inc.
Manufacturer SRN: US-MF-000013697
UDI-DI: 00883205103499
Basic UDI-DI: 0883205-TF049B9
Reference: 351
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: -
Authorised representative: Ultradent Products GmbH
Last updated: 16.07.2026 06:17

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OraSeal Putty Econo Refill

Class IMDR 2017/745On the market

Manufacturer: Ultradent Products, Inc.
Manufacturer SRN: US-MF-000013697
UDI-DI: 00883205103543
Basic UDI-DI: 0883205-TF049B9
Reference: 355
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: -
Authorised representative: Ultradent Products GmbH
Last updated: 16.07.2026 06:17

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08435567315335

Non-Implantable Attachments, Casting cylinders

Class IMDR 2017/745On the marketSingle use

Manufacturer: Phibo Dental Solutions S.L.
Manufacturer SRN: ES-MF-000024464
UDI-DI: 08435567315335
Basic UDI-DI: 084355673CASTCD
Reference: 016.3100
EMDN: Q019005
EMDN description: CASTABLE DENTAL POSTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 05:21

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NeoDiamond

Diamond Coated Dental Flexible Strips

Class IMDR 2017/745On the market

Manufacturer: Microcopy, A Division of Neo-Flo, Inc.
Manufacturer SRN: US-MF-000012637
UDI-DI: 00840221637704
Basic UDI-DI: 08402216STRIPINT42
Reference: DSS-25M-MS
EMDN: Q019003
EMDN description: DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:59

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DrDrys

Saliva Absorbents - Non Sterile

Class IMDR 2017/745On the marketSingle use

Manufacturer: Microcopy, A Division of Neo-Flo, Inc.
Manufacturer SRN: US-MF-000012637
UDI-DI: 00818963020078
Basic UDI-DI: 081896302DRDRYD7
Reference: DRDRYL
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: Finland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:32

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NeoDry

Saliva Absorbents - Non Sterile

Class IMDR 2017/745On the marketSingle use

Manufacturer: Microcopy, A Division of Neo-Flo, Inc.
Manufacturer SRN: US-MF-000012637
UDI-DI: 00818963020016
Basic UDI-DI: 081896302DYSKS
Reference: DYL
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:32

Manufacturer products Authorised representative products Authorised representative actors View details

Prime Dent Light Cure Dental Dam

TF16

Class IMDR 2017/745On the market

Manufacturer: Prime Dental Manufacturing
Manufacturer SRN: US-MF-000008807
UDI-DI: 00817441023440
Basic UDI-DI: 081744102TF165J
Reference: 021-011
EMDN: Q019002
EMDN description: DENTISTRY DAMS AND HOOKS, SINGLE-USE
First on market country: Spain
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

S377

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000529060
Basic UDI-DI: 081000052BRUSHTIPEU
Reference: S377
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

S535

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000528285
Basic UDI-DI: 081000052MIXINGTIP5K5
Reference: S535
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Dispensing Tip

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000527608
Basic UDI-DI: 081000052NEEDLETIPFU
Reference: S621
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Applicator Brush

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000527561
Basic UDI-DI: 081000052APPBRUSH84
Reference: S379
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing Tip 3

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526977
Basic UDI-DI: 081000052MIXINGTIP3JZ
Reference: S439IOT
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Application Tips

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526960
Basic UDI-DI: 081000052NEEDLETIP4ZK
Reference: S383
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing/Dispensing Tips

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526861
Basic UDI-DI: 081000052MIXINGTIPWR
Reference: S302
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing Tip 4

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526854
Basic UDI-DI: 081000052MIXINGTIP4K3
Reference: S292
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Mixing Tip 2

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526847
Basic UDI-DI: 081000052MIXINGTIP2JX
Reference: S275
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Pre-Bent Needle Tip

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526830
Basic UDI-DI: 081000052NEEDLETIP2ZF
Reference: S390
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Luer Lock Applicator Tips

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526809
Basic UDI-DI: 081000052NEEDLETIP3ZH
Reference: S181
EMDN: Q019006
EMDN description: DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Henry Schein

TF-121

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Henry Schein Inc.
Manufacturer SRN: US-MF-000021683
UDI-DI: H65890030491
Basic UDI-DI: 03040412101AX
Reference: 9003049
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: Germany
Authorised representative: Henry Schein Services GmbH
Last updated: 15.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details