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00817421020322

P008835

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421020322
Basic UDI-DI: B-00817421020322
Reference: P008835
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR

FARASTAR Pulsed Field Ablation Generator

Class IIbMDDOn the marketActive device

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180126
Basic UDI-DI: B-00810087180126
Reference: 61M401
EMDN: Z120101
EMDN description: ARTERIOTOMY ABLATORS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Foot pedal On/Off

Class IMDR 2017/745On the marketActive device

Manufacturer: NOUVAG AG
Manufacturer SRN: CH-MF-000018882
UDI-DI: +ENOU1527NOU09
Basic UDI-DI: ++ENOU100031LG
Reference: 1527nou
EMDN: Z12019080
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Nouvag Dental- und Medizintechnik GmbH
Last updated: 01.08.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

Foot pedal Vario

Class IMDR 2017/745On the marketActive device

Manufacturer: NOUVAG AG
Manufacturer SRN: CH-MF-000018882
UDI-DI: +ENOU1861NOU0A
Basic UDI-DI: ++ENOU100031LG
Reference: 1861nou
EMDN: Z12019080
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Nouvag Dental- und Medizintechnik GmbH
Last updated: 01.08.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

Foot pedal Vario

Class IMDR 2017/745On the marketActive device

Manufacturer: NOUVAG AG
Manufacturer SRN: CH-MF-000018882
UDI-DI: +ENOU1866NOU0F
Basic UDI-DI: ++ENOU100031LG
Reference: 1866nou
EMDN: Z12019080
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Nouvag Dental- und Medizintechnik GmbH
Last updated: 01.08.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

Blades for Dermatome

Class IIaMDDOn the marketSingle useSterile

Manufacturer: NOUVAG AG
Manufacturer SRN: CH-MF-000018882
UDI-DI: +ENOU19199W
Basic UDI-DI: B-+ENOU19199W
Reference: 1919
EMDN: Z120103
EMDN description: DERMOTOMY EQUIPMENT
First on market country: Germany
Authorised representative: Nouvag Dental- und Medizintechnik GmbH
Last updated: 01.08.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

FlexSys

1070

Class IIbMDDOn the marketActive device

Manufacturer: GME German Medical Engineering GmbH
Manufacturer SRN: DE-MF-000009384
UDI-DI: +B12510700P
Basic UDI-DI: B-+B12510700P
Reference: 1070
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Germany
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

VisiMARKER

Class IMDDOn the marketSingle useSterile

Manufacturer: Clear Guide Medical
Manufacturer SRN: US-MF-000031413
UDI-DI: ++B201CGVM0
Basic UDI-DI: B-++B201CGVM0
Reference: CG-VM
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

TipTAG

Class IMDDOn the marketSingle useSterile

Manufacturer: Clear Guide Medical
Manufacturer SRN: US-MF-000031413
UDI-DI: ++B201CGTT0
Basic UDI-DI: B-++B201CGTT0
Reference: CG-TT
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

SCENERGY

Class IIaMDDNo longer on the marketActive device

Manufacturer: Clear Guide Medical
Manufacturer SRN: US-MF-000031413
UDI-DI: ++B201CGSCENERGY0
Basic UDI-DI: B-++B201CGSCENERGY0
Reference: CG-SCENERGY
EMDN: Z12011492
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

ITL EssentialsTM Quiver with PVC Loop NS

Quiver

Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: ITL Asia Pacific Sdn. Bhd.
Manufacturer SRN: MY-MF-000001570
UDI-DI: 19555240400557
Basic UDI-DI: 955524040QVRNSMP
Reference: A100396
EMDN: Z12010999
EMDN description: ELECTROSURGERY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

ITL EssentialsTM Quiver Laparoscopic Extendable with PVC Loop

Quiver

Class IMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: ITL Asia Pacific Sdn. Bhd.
Manufacturer SRN: MY-MF-000001570
UDI-DI: 19555240400854
Basic UDI-DI: 955524040QVRSM8
Reference: A100604
EMDN: Z12010999
EMDN description: ELECTROSURGERY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

ATO ML600B

ATO ML

Class IMDR 2017/745On the marketActive device

Manufacturer: Photonic Optische Geräte GesmbH&CoKG
Manufacturer SRN: AT-MF-000007155
UDI-DI: 09120127130013
Basic UDI-DI: 9120127130000012X
Reference: 4500-4000
EMDN: Z12010799
EMDN description: SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

System HeadSTEP Bite Narrow

HeadSTEP Bite Systems

Class IMDR 2017/745On the market

Manufacturer: IT-V Medizintechnik GmbH
Manufacturer SRN: AT-MF-000001918
UDI-DI: 09120074397897
Basic UDI-DI: 91200743918M6
Reference: P10107-789
EMDN: Z12011280
EMDN description: PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:38

Manufacturer products View details

System BellySTEP

BellySTEP Systems