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EUDAMED Device Search

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

Last updated

05.07.2026 16:44

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Active filter:Manufacturer SRN:US-MF-000012885

7 device results listed.

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Snore Aid

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121035510
Basic UDI-DI: 69212103551NN
Reference: many
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Estonia
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Select-Comfort

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121035435
Basic UDI-DI: 69212103543NP
Reference: 03543
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Estonia
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

ProRx

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121035213
Basic UDI-DI: 69212103521ND
Reference: 03521
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Estonia
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Dura-Comfort

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121032243
Basic UDI-DI: 69212103224N4
Reference: 03224
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Estonia
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra-Comfort

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121032069
Basic UDI-DI: 69212103206N2
Reference: 03206
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Estonia
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Secure-Comfort

Class IMDR 2017/745On the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 10692121032052
Basic UDI-DI: 69212103205MY
Reference: 03205
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Netherlands
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 02.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

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Class INot specifiedOn the market

Manufacturer: Splintek, Inc.
Manufacturer SRN: US-MF-000012885
UDI-DI: 00692121035568
Basic UDI-DI: 0692121SR-SNORE-AID6H
Reference: -
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: -
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 30.05.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details