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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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361 device results listed.

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Parkell®

Metal Probes

Class IIaMDDOn the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520459
Basic UDI-DI: B-00810000520459
Reference: D625
EMDN: Z12119005
EMDN description: PULP VITALITY ANALYSERS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 01.08.2026 10:12

Manufacturer products Authorised representative products Authorised representative actors View details

OrthoCare Aligner Remover tool

9001-ART02

Class IMDR 2017/745On the market

Manufacturer: Ortho-Care (UK) Limited
Manufacturer SRN: GB-MF-000010884
UDI-DI: 05056334600251
Basic UDI-DI: 50563346ALIGNERREMRUIL5
Reference: 9001-ART02
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Sweden
Authorised representative: Directa AB
Last updated: 31.07.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

Orthocare Aligner Remover tool

Class INot specifiedOn the market

Manufacturer: Ortho-Care (UK) Limited
Manufacturer SRN: GB-MF-000010884
UDI-DI: 05056334600985
Basic UDI-DI: 50563346ALIGNERREMRUIL5
Reference: 9001-ART02
EMDN: Q010499
EMDN description: ORTHODONTIC DEVICES - OTHER
First on market country: Sweden
Authorised representative: Directa AB
Last updated: 31.07.2026 19:35

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: 30.07.2026 19:47

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: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Unit Dose Dispensing Gun

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000526819
Basic UDI-DI: 081000052MIXINGGUN2HS
Reference: S189
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

AccuFilm

AccuFilm IV

Class IMDR 2017/745No longer on the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000526116
Basic UDI-DI: 081000052AFS020D6
Reference: S020
EMDN: Q01020202
EMDN description: SPRAY AND LIQUID DENTAL CONTACT INDICATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Hedgehog™

HedgeHog Burs

Class IMDR 2017/745No longer on the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000524280
Basic UDI-DI: 081000052HEDGEHOGVU
Reference: S497
EMDN: L159007
EMDN description: ODONTOSTOMATOLOGY BURS, REUSABLE
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Cinch®

Cinch, Mousse & Mach Impression Materials

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000524075
Basic UDI-DI: 081000052IMPRESSIONL3
Reference: S464
EMDN: Q01020102
EMDN description: DENTAL IMPRESSION VINYLSILOXANS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Parkell®

Water Filter

Class IMDR 2017/745On the market

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000522040
Basic UDI-DI: 081000052WATERFILTERC7
Reference: D418
EMDN: Z12119080
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

TurboSENSOR®

Handpiece Sheath

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520572
Basic UDI-DI: 081000052SHEATHR5
Reference: D576
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

PureClarity™

D718, D719

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521579
Basic UDI-DI: 0081000052CLARITYJ4
Reference: D719
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Germany
Authorised representative: Directa AB
Last updated: 30.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

TurboVUE™

Class INot specifiedNo longer on the marketDirect marking

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000520848
Basic UDI-DI: 081000052SHEATHR5
Reference: D572
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: -
Authorised representative: Directa AB
Last updated: 28.07.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

PureClarity™

Class INot specifiedOn the marketDirect marking

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000521647
Basic UDI-DI: 0081000052CLARITYJ4
Reference: D718
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: -
Authorised representative: Directa AB
Last updated: 28.07.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Blu-Mousse®

Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Parkell Inc.
Manufacturer SRN: US-MF-000003761
UDI-DI: 00810000524143
Basic UDI-DI: 081000052IMPRESSIONL3
Reference: S436
EMDN: Q01020102
EMDN description: DENTAL IMPRESSION VINYLSILOXANS
First on market country: -
Authorised representative: Directa AB
Last updated: 28.07.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Hedgehog™