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Mini Fiber Optic Otoscope - Sky Blue

OT10P

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: HASH SIGN
Manufacturer SRN: PK-MF-000057792
UDI-DI: 08964005004918
Basic UDI-DI: 8964005004OT10P5A
Reference: OT10P
EMDN: Z12021007
EMDN description: MIDDLE EAR OTOSCOPES
First on market country: Germany
Authorised representative: KHANG BAO INTERNATIONAL KFT
Last updated: 23.09.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

AIO Base Plate

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028749289
Basic UDI-DI: 5420028700304T
Reference: 32204
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 19:03

Manufacturer products View details

AXA Scanbody kit for R2 Photogram

R2 Photogram

Class IMDR 2017/745On the marketActive device

Manufacturer: MegaGen Implant Co., Ltd.
Manufacturer SRN: KR-MF-000009885
UDI-DI: 08800292994863
Basic UDI-DI: 880972899221PW
Reference: R2M-AXA-SB-SET
EMDN: Z12119099
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 23.09.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Prone Head Support for multipoint

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028746653
Basic UDI-DI: 5420028700304T
Reference: 32379
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 18:53

Manufacturer products View details

Reusable EKG / ECG Leadwire

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870343901
Basic UDI-DI: 86988703FMTEKGECGLEADR7
Reference: E52-3I
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 18:49

Manufacturer products View details

Venuscon

Countersink

Class IIaMDR 2017/745On the marketAdministering medicineReusableSingle use

Manufacturer: MEDİSOLARİS SAĞLIK HİZMETLERİ
Manufacturer SRN: TR-MF-000015946
UDI-DI: 08683190205510
Basic UDI-DI: 868319020022H7
Reference: CBD 3700
EMDN: Z12110102
EMDN description: DENTAL DRILLS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 18:46

Manufacturer products View details

SBRT Solution - Long SBRT Base Plate

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028746479
Basic UDI-DI: 5420028700304T
Reference: 32317/30
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 18:43

Manufacturer products View details

C-NW

Accessory foot control wireless Prophy&Paro/R&P/Endo

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: W & H Dentalwerk Bürmoos GmbH
Manufacturer SRN: AT-MF-000001590
UDI-DI: +J021303160001
Basic UDI-DI: ++J021ACC00027A
Reference: 30316000
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: Austria
Authorised representative: -
Last updated: 23.09.2026 18:36

Manufacturer products View details

2-pin bar for SBRT long base plate

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028744567
Basic UDI-DI: 5420028700304T
Reference: 32317/29
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 18:33

Manufacturer products View details

MyCareLink™

PATIENT MONITOR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000834609
Basic UDI-DI: 0763000B00002006Q
Reference: 24952
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

C-NW

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: W & H Dentalwerk Bürmoos GmbH
Manufacturer SRN: AT-MF-000001590
UDI-DI: +J021303160021
Basic UDI-DI: ++J021ACC00027A
Reference: 30316002
EMDN: Z12119001
EMDN description: TARTAR ABLATORS
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 18:30

Manufacturer products View details

FLH332

FLH-3

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Ordisi, S.A
Manufacturer SRN: ES-MF-000000987
UDI-DI: 08435205027484
Basic UDI-DI: 84352050FLH3L6
Reference: FLH332
EMDN: Z129004
EMDN description: LIGHT SOURCES
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 18:26

Manufacturer products View details

SP-L01

Array Probes (SP-L01, GP-C01, DLX-200-USP)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Interson Corporation
Manufacturer SRN: US-MF-000020801
UDI-DI: 00850921007127
Basic UDI-DI: 0850921007INT222UT
Reference: 99-7901-00
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.09.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

DLX-200-USP

Array probe

Class IIaMDDOn the marketActive device

Manufacturer: Interson Corporation
Manufacturer SRN: US-MF-000020801
UDI-DI: 00850921007271
Basic UDI-DI: 0850921007INT222UT
Reference: 99-9028-00
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.09.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

GP-C01

Array probe

Class IIaMDDOn the marketActive device

Manufacturer: Interson Corporation
Manufacturer SRN: US-MF-000020801
UDI-DI: 00850921007004
Basic UDI-DI: 0850921007INT222UT
Reference: 99-7903-00
EMDN: Z110402010201
EMDN description: CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.09.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

FOA03MM0804

ADHESIVE FOAM

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: OT Bioelettronica srl
Manufacturer SRN: IT-MF-000033348
UDI-DI: 08056977852915
Basic UDI-DI: 805697785FOAMSHEET010KP
Reference: OT0369
EMDN: Z12100785
EMDN description: EMG TELEMETRY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 23.09.2026 18:25

Manufacturer products View details

ColoFlex™N

Class IIaMDDOn the market

Manufacturer: MAUNA KEA TECHNOLOGIES
Manufacturer SRN: FR-MF-000000835
UDI-DI: 03760187912035
Basic UDI-DI: 376018791NCM2DX
Reference: FP-10031
EMDN: Z12020685
EMDN description: LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 23.09.2026 18:23

Manufacturer products View details

AIO 3.0 - Base plate CFL - Without leg s

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028743409
Basic UDI-DI: 5420028700304T
Reference: 38018
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 18:23

Manufacturer products View details

MyCareLink™

PATIENT MONITOR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000834586
Basic UDI-DI: 0763000B00002006Q
Reference: 24952
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Master V3

CGM MB-1101

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CERAGEM Co., Ltd.
Manufacturer SRN: KR-MF-000011973
UDI-DI: 08809494000006
Basic UDI-DI: B-08809494000006
Reference: E3VN001409
EMDN: Z120602
EMDN description: PHYSIOTHERAPY EQUIPMENT
First on market country: Germany
Authorised representative: Ceragem Europe GmbH
Last updated: 23.09.2026 18:20

Manufacturer products Authorised representative products Authorised representative actors View details