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SmartMix™ Vacuum Syringe

HiVac™ 7

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238201350
Basic UDI-DI: 50602382003A5K
Reference: 5401-76-510
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMix™ Curettes

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238201305
Basic UDI-DI: 50602382001D5K
Reference: 5401-10-002
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

Mixing bowl, Spatula

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200186
Basic UDI-DI: 50602382008A62
Reference: 5401-38-000
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMix™ Vacuum Footpump + Air Hose

Vacuum Footpump

Class IMDR 2017/745On the marketActive device

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200148
Basic UDI-DI: 50602382009A65
Reference: 5401-96-500
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMix™ 65º Nozzle

Nozzles

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200117
Basic UDI-DI: 50602382007A5X
Reference: 5401-50-000
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMix™ CTS Vacuum Mixing Bowl

Vacuum Bowl

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200070
Basic UDI-DI: 50602382001A5D
Reference: 5401-76-501
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 02:14

Manufacturer products Authorised representative products Authorised representative actors View details

High Viscosity Injection System

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177043107
Basic UDI-DI: 376017704B25D8
Reference: T060421
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

VACUUKIT

Vacuum Mixing & Injection System for bone cement

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177042919
Basic UDI-DI: 376017704B21CY
Reference: T060416
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

MedV+

Class IMDR 2017/745On the marketSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-PR-000001226
UDI-DI: 03760177042186
Basic UDI-DI: 376017704B30CZ
Reference: T060417
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

EasyKit M

Mixing and injection system for bone cement

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177042117
Basic UDI-DI: 376017704B22D2
Reference: T060415
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

S5M

Mixing and Injection System for Bone Cement

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177041950
Basic UDI-DI: 376017704B24D6
Reference: T060407
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

Mini-Malax

Mixing and injection system for bone cement

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177040175
Basic UDI-DI: 376017704B23D4
Reference: T060406
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

Bowl & Spatula

Class IMDR 2017/745On the marketSingle use

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03760177040151
Basic UDI-DI: 376017704B12CX
Reference: T060404
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

HV 1300 - Spinal cement system

HIGHV+ - Spinal Cement System

Class IIIMDR 2017/745On the marketSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-PR-000001226
UDI-DI: 03701505801198
Basic UDI-DI: 376017704B28DE
Reference: T040326K
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 15:12

Manufacturer products View details

PureKIT Syringes

Mixing and injection system for bone cement

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-MF-000001224
UDI-DI: 03701505801075
Basic UDI-DI: 376017704B33D7
Reference: T060426
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:12

Manufacturer products View details

PureKit Syringes 4cc/LV

PUREKIT LV

Class IIIMDR 2017/745On the marketSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-PR-000001226
UDI-DI: 03701505800504
Basic UDI-DI: 376017704B35DB
Reference: T060426LV
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 15:12

Manufacturer products View details

PureKit Syringes 4cc/MV

PUREKIT MV

Class IIIMDR 2017/745On the marketSterile

Manufacturer: TEKNIMED SAS
Manufacturer SRN: FR-PR-000001226
UDI-DI: 03701505800498
Basic UDI-DI: 376017704B34D9
Reference: T060426MV
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 15:12

Manufacturer products View details

SmartMix™ 90º Flanged Nozzle

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200131
Basic UDI-DI: 50602382007A5X
Reference: 5401-52-000
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

High Vacuum Footpump

Class IMDR 2017/745On the marketActive device

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200278
Basic UDI-DI: 50602382009A65
Reference: H550
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

Vacu-Mix® Low Vacuum Footpump + Air hose

Class IMDR 2017/745On the marketActive device

Manufacturer: Summit Medical Ltd
Manufacturer SRN: GB-MF-000019193
UDI-DI: 15060238200292
Basic UDI-DI: 50602382009A65
Reference: 3210025
EMDN: P099002
EMDN description: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details