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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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174 device results listed.

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Parkell®

Mixing Well

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000529657
Basic UDI-DI: 081000052MIXINGWELLL6
Reference: S373
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:34

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

Accu-Film®

Accu-Film® Fast-Check

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000528148
Basic UDI-DI: 081000052AFS054DP
Reference: S054
EMDN: Q01020201
EMDN description: ARTICULATION PAPERS
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

DryZ®

DryZ Gingival Retraction Paste

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000525086
Basic UDI-DI: 081000052DRYZXK
Reference: S180
EMDN: Q010204
EMDN description: RETRACTION WIRES AND GINGIVAL RETRACTORS
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

AccuFilm I

AccuFilm I & II

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000526076
Basic UDI-DI: 081000052AFI&IICY
Reference: S014
EMDN: Q01020201
EMDN description: ARTICULATION PAPERS
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®

Impression Tray

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000524119
Basic UDI-DI: 081000052TRAYYR
Reference: S431
EMDN: Q010503
EMDN description: IMPRESSION MATERIAL TRAYS, 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®

Handpiece Holder

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000521552
Basic UDI-DI: 081000052HPHOLDER8T
Reference: D323
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
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®

O-Ring

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 10810000520630
Basic UDI-DI: 081000052ORINGUT
Reference: D588
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
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 Gun 3

Class IMDR 2017/745No longer on the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000528134
Basic UDI-DI: 081000052MIXINGGUN3HU
Reference: S349
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Dispensing Gun

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000526895
Basic UDI-DI: 081000052MIXINGGUNVQ
Reference: S327
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Germany
Authorised representative: Directa AB
Last updated: 16.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details