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Sugita T2 Clip Tray I. (Customizable Tray for Standard, Mini and Long clips with 20 blank pockets)

Class INot specifiedOn the marketDirect marking

Manufacturer: MIZUHO Corporation
Manufacturer SRN: JP-MF-000019215
UDI-DI: 04946329221114
Basic UDI-DI: 49463290307004UE
Reference: 17-010-98
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sugita T2 Clip Tray J. (For Temporary clips 001-51 to 58 only)

Class INot specifiedOn the marketDirect marking

Manufacturer: MIZUHO Corporation
Manufacturer SRN: JP-MF-000019215
UDI-DI: 04946329221121
Basic UDI-DI: 49463290307004UE
Reference: 17-010-99
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

ShroudGuard

37110

Class IMDDOn the market

Manufacturer: D. A. Surgical
Manufacturer SRN: US-MF-000008785
UDI-DI: 00811836030600
Basic UDI-DI: B-00811836030600
Reference: 37220
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:20

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ShroudGuard

37303

Class IMDDOn the market

Manufacturer: D. A. Surgical
Manufacturer SRN: US-MF-000008785
UDI-DI: 00811836030075
Basic UDI-DI: B-00811836030075
Reference: 37303
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

CLOSED HEAD RING

Operation Room Gel Positioning Pad

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Libertech Corporation
Manufacturer SRN: KR-MF-000024126
UDI-DI: 08809238795014
Basic UDI-DI: 880923879LBT001LM
Reference: AP001
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: JaviTech e.K.
Last updated: 03.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

Handoperatietafel volgens Simonetta

Patient positioning instruments

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medex Instrumenten Service
Manufacturer SRN: NL-MF-000010798
UDI-DI: 08720261240725
Basic UDI-DI: 872026124NIRD039D
Reference: ME00-002
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:47

Manufacturer products View details

CNERGY - Couch Control

C01-01-01

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Cablon Medical B.V.
Manufacturer SRN: NL-MF-000002582
UDI-DI: 08717953004024
Basic UDI-DI: 87179530040C01-01-01XZ
Reference: C01-01-01
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:23

Manufacturer products View details

Soporte lateral simple

Lateral support

Class IMDR 2017/745On the market

Manufacturer: Ansabere Surgical S.L
Manufacturer SRN: ES-MF-000006144
UDI-DI: 08436578941971
Basic UDI-DI: 843657894AN0440DM
Reference: A610
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:44

Manufacturer products View details

00841962120500

Aquaplast RT and Fibreplast

Class IMDR 2017/745On the market

Manufacturer: Qfix
Manufacturer SRN: US-MF-000002762
UDI-DI: 00841962120500
Basic UDI-DI: 8419621RTTHERMOPF
Reference: RT-E778KPR2H
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 03.07.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

00841962119696

Head and Neck

Class IMDR 2017/745On the marketReusable

Manufacturer: Qfix
Manufacturer SRN: US-MF-000002762
UDI-DI: 00841962119696
Basic UDI-DI: 8419621HEADNECKX4
Reference: RT-4600-12
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 03.07.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

00841962119627

SBRT Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Qfix
Manufacturer SRN: US-MF-000002762
UDI-DI: 00841962119627
Basic UDI-DI: 8419621SBRT8G
Reference: RT-4489STRAP
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 03.07.2026 13:00

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MultiFix 2

Couchtops, Overlays, and Multipurpose Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Qfix
Manufacturer SRN: US-MF-000002762
UDI-DI: 00841439115305
Basic UDI-DI: 8419621COUCHTOPSMPD6F
Reference: RT-5411
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 03.07.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

00841439112489

Stereotactic Radiosurgery and Stereotactic Radiotherapy Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Medtec LLC
Manufacturer SRN: US-MF-000002608
UDI-DI: 00841439112489
Basic UDI-DI: 8414391OC0019R01BX
Reference: CHS03
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 03.07.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Modified Gaston Hook

Hip Patient positioner

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Medacta International SA
Manufacturer SRN: CH-MF-000033473
UDI-DI: 07630542797019
Basic UDI-DI: 764014274HSR0031N007B
Reference: 01.19.10.010
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: Medacta Italia srl
Last updated: 03.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

07350111833091

Armboard

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Reison Medical AB
Manufacturer SRN: SE-MF-000002468
UDI-DI: 07350111833091
Basic UDI-DI: 735011183ARMBOARDM6
Reference: 20-300
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:58

Manufacturer products View details

ASSY, PAD, ARM BOARD, 3"

Class IMDR 2017/745On the market

Manufacturer: Mizuho Orthopedic Systems, Inc.
Manufacturer SRN: US-MF-000002901
UDI-DI: 00842430100611
Basic UDI-DI: 0842430158956Y
Reference: 5366-7000
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAD, ARMBOARD, 1"

Class IMDR 2017/745On the market

Manufacturer: Mizuho Orthopedic Systems, Inc.
Manufacturer SRN: US-MF-000002901
UDI-DI: 00842430100383
Basic UDI-DI: 0842430158956Y
Reference: 5379-7722
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details

5' IMAGING TOP PAD ASSEMBLY

Class IMDR 2017/745On the market

Manufacturer: Mizuho Orthopedic Systems, Inc.
Manufacturer SRN: US-MF-000002901
UDI-DI: 00842430101793
Basic UDI-DI: 0842430158956Y
Reference: 5806-7010
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAD ASSEMBLY, HIP LIFTER

Class IMDR 2017/745On the market

Manufacturer: Mizuho Orthopedic Systems, Inc.
Manufacturer SRN: US-MF-000002901
UDI-DI: 00842430101816
Basic UDI-DI: 0842430158956Y
Reference: 5847-7255
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details

PAD ASSEMBLY, TABLE

Class IMDR 2017/745On the market

Manufacturer: Mizuho Orthopedic Systems, Inc.
Manufacturer SRN: US-MF-000002901
UDI-DI: 00842430101823
Basic UDI-DI: 0842430158956Y
Reference: 5847-7276
EMDN: Z12011299
EMDN description: PATIENT POSITIONING INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 22:32

Manufacturer products Authorised representative products Authorised representative actors View details