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DynaCAD

DynaCAD 5

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips DS North America LLC
Manufacturer SRN: US-MF-000035802
UDI-DI: 00884838094857
Basic UDI-DI: 0884838BM426SY
Reference: 300010314352
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

MR-RT CouchTop

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Philips Oy
Manufacturer SRN: FI-MF-000001621
UDI-DI: 00884838068490
Basic UDI-DI: 0884838BM289TE
Reference: 459800573514
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

Prodiva 1.5T CS

Prodiva 1.5T

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838064799
Basic UDI-DI: 0884838BM288TC
Reference: 781069
EMDN: Z11050103
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY GREATER THAN 0.5T
First on market country: France
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

8Tx32Rx 7T Head Coil Clinic

8893279

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nova Medical Inc
Manufacturer SRN: US-MF-000009719
UDI-DI: 00866613000352
Basic UDI-DI: 086661300037T88932796N
Reference: 8893279
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

2Tx32Rx 7T Head Coil

4318932

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nova Medical Inc
Manufacturer SRN: US-MF-000009719
UDI-DI: 00866613000338
Basic UDI-DI: 086661300037T4318932Z2
Reference: 4318932
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

1Tx32Rx 7T Head Coil Clinic

1893279

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nova Medical Inc
Manufacturer SRN: US-MF-000009719
UDI-DI: 00866613000314
Basic UDI-DI: 086661300037T18932792X
Reference: 1893279
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

3T 32 CH Head Coil MR 750

3832016

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nova Medical Inc
Manufacturer SRN: US-MF-000009719
UDI-DI: 00866613000307
Basic UDI-DI: 086661300033T32CHJ9
Reference: 3832016
EMDN: Z11059080
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

00860000606134

810-11049-01

Class IMDR 2017/745On the market

Manufacturer: Hyperfine, Inc.
Manufacturer SRN: US-MF-000029806
UDI-DI: 00860000606134
Basic UDI-DI: 0860000606100003R7
Reference: 810-11049-01
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Swoop® Portable MR Imaging® System

850-11001-06 (900-11001-06, in crate)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Hyperfine, Inc.
Manufacturer SRN: US-MF-000029806
UDI-DI: 00850043319009
Basic UDI-DI: 0860000606100001R3
Reference: 900-11001-06
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

PNEUMO NONMETALIC 10' LATEX FREE

Latex-Free Non- Metallic Pneumograph

Class IMDR 2017/745On the market

Manufacturer: Lafayette Instrument Company
Manufacturer SRN: US-MF-000041816
UDI-DI: 00855170007140
Basic UDI-DI: 0855170007NMPNEUMOGRAPHU9
Reference: 76513NM10A
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Germany
Authorised representative: AJW Technology Consulting GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T 16ch Shoulder Coil

16ch Shoulder Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003909
Basic UDI-DI: 0850028932377Q
Reference: NC143202
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T 16ch Breast Coil

16ch Breast Coil

Class IMDR 2017/745On the marketActive device

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003824
Basic UDI-DI: 0850028932387S
Reference: M7006PA
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T Receive-Only 16ch Flex SPEEDER Large

16ch Flex SPEEDER Coils

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003169
Basic UDI-DI: 0850028932397U
Reference: NC043200
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

GEM Flex Interface 16ch Fixed, 1.5T P-Connector

GEM Flex Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003060
Basic UDI-DI: 0850028932407D
Reference: NC022204
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T HD 8Ch Shoulder Coil

8Ch Shoulder Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003046
Basic UDI-DI: 0850028932417F
Reference: NC008901
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

Biopsy Grid

Biopsy Accessories

Class IMDR 2017/745On the marketSingle use

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932315
Basic UDI-DI: 0850028932337G
Reference: NC088444
EMDN: Z11059085
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T AIR Open Head Neck Posterior 9ch

32Ch AIR Open Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932254
Basic UDI-DI: 0850028932437K
Reference: NC139200
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Extremities Stabilizer Kit, Flex Coils

Flex Coil Accessories

Class IMDR 2017/745On the market

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932131
Basic UDI-DI: 0850028932357L
Reference: NC074004
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Guardian G1 Wireless Audio System

Wireless Audio System

Class IMDR 2017/745On the marketActive device

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932155
Basic UDI-DI: 0850028932347J
Reference: NC070000
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Resoundant MR Elastography System

RESYS4001-RESYSAB

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Resoundant
Manufacturer SRN: US-MF-000037180
UDI-DI: 00850011790274
Basic UDI-DI: 0850011790RESYS4001-AB9T
Reference: RESYS4001-RESYSAB
EMDN: Z11059099
EMDN description: VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: VISAMED GmbH
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details