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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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PicoWay Laser System

Class IIbMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495021010
Basic UDI-DI: B-00817495021010
Reference: 9914-12-9060
EMDN: Z12011006
EMDN description: DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
First on market country: Belgium
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Aesthetica

9914-08-0320

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020174
Basic UDI-DI: B-00817495020174
Reference: 9914-08-0320
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Platinum

9914-08-0310

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020167
Basic UDI-DI: B-00817495020167
Reference: 9914-08-0310
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Aesthetica

9914-00-0320

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020150
Basic UDI-DI: B-00817495020150
Reference: 9914-00-0320
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Platinum

9914-00-0310

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020143
Basic UDI-DI: B-00817495020143
Reference: 9914-00-0310
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Perfecta

9914-00-0300

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020136
Basic UDI-DI: B-00817495020136
Reference: 9914-00-0300
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

GentleLASE Pro-U

9914-00-9030

Class IIbMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020082
Basic UDI-DI: B-00817495020082
Reference: 9914-00-9035
EMDN: Z12011017
EMDN description: NEODYMIUM SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

GentleYAG Pro-U

9914-00-9020

Class IIbMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020044
Basic UDI-DI: B-00817495020044
Reference: 9914-00-9020
EMDN: Z12011006
EMDN description: DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

PicoWay Laser System

Class IIbMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020037
Basic UDI-DI: B-00817495020037
Reference: 9914-00- 9060
EMDN: Z12011006
EMDN description: DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
First on market country: Belgium
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vbeam Perfecta

9914-08-0300

Class IIaMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020020
Basic UDI-DI: B-00817495020020
Reference: 9914-08-0300
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gentle Max Pro

9914-00-9035

Class IIbMDDOn the marketActive device

Manufacturer: Candela Corporation
Manufacturer SRN: US-MF-000022750
UDI-DI: 00817495020013
Basic UDI-DI: B-00817495020013
Reference: 9914-00-9035
EMDN: Z12011012
EMDN description: DYE/ALEXANDRITE SURGICAL LASER
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

X-Guide

P011000

Class IIaMDDOn the marketActive deviceReusable

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021794
Basic UDI-DI: B-00817421021794
Reference: P011000
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021442

Class IIaNot specifiedOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021442
Basic UDI-DI: B-00817421021442
Reference: P010925
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021428

Class IIaNot specifiedOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021428
Basic UDI-DI: B-00817421021428
Reference: P010924
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021404

P010923

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021404
Basic UDI-DI: B-00817421021404
Reference: P010923
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021381

P010922

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021381
Basic UDI-DI: B-00817421021381
Reference: P010922
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021367

P010921

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021367
Basic UDI-DI: B-00817421021367
Reference: P010921
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421021343

P010920

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421021343
Basic UDI-DI: B-00817421021343
Reference: P010920
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

X-Guide

P008843

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421020469
Basic UDI-DI: B-00817421020469
Reference: P008843
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

00817421020445

P008842

Class IIaMDDOn the marketSingle use

Manufacturer: X-Nav Technologies, LLC
Manufacturer SRN: US-MF-000003234
UDI-DI: 00817421020445
Basic UDI-DI: B-00817421020445
Reference: P008842
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