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AM3010TJ

Astramax

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Brandon Medical Company Limited
Manufacturer SRN: GB-MF-000005501
UDI-DI: 05060413441345
Basic UDI-DI: 506041344AM30XF
Reference: AM3010TJ
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Ireland
Authorised representative: RegTrac Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

AL10MO

Astralite

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Brandon Medical Company Limited
Manufacturer SRN: GB-MF-000005501
UDI-DI: 05060413441338
Basic UDI-DI: 506041344AL10X4
Reference: AL10MO
EMDN: Z12010799
EMDN description: SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: RegTrac Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

LED 300 DF Single colour Surgical LED lamp

Overhead Operating Lights

Class IMDR 2017/745On the market

Manufacturer: Kenex (Electro-Medical) Limited
Manufacturer SRN: GB-MF-000009022
UDI-DI: 05055449403153
Basic UDI-DI: 50554494LIOWP
Reference: 340/630/03
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:16

Manufacturer products Authorised representative products Authorised representative actors View details

LED 150F Focusable LED examination and small operating lamps

Overhead examination/operating lighting

Class IMDR 2017/745On the market

Manufacturer: Kenex (Electro-Medical) Limited
Manufacturer SRN: GB-MF-000009022
UDI-DI: 05055449401760
Basic UDI-DI: 50554494LIMWK
Reference: 300/L-LED150F
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:16

Manufacturer products Authorised representative products Authorised representative actors View details

K-LED + Double Charger+2 Battery

K-LED II

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272703277
Basic UDI-DI: 50552727KLEDMC
Reference: 2004-P-1007
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Belgium
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 31.07.2026 08:08

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Universal Light Handle, for use with ‘DRAEGER Sola’

TF1012

Class IMDR 2017/745On the marketSingle use

Manufacturer: Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
Manufacturer SRN: GB-MF-000012819
UDI-DI: 05051223000884
Basic UDI-DI: 50512230LHANDLE6X
Reference: PS9944
EMDN: Z12010780
EMDN description: SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:01

Manufacturer products Authorised representative products Authorised representative actors View details

Blue Dot Pen Torch (Each)

Pen torch

Class IMDR 2017/745On the marketActive deviceAnimal tissuesReusable

Manufacturer: Crest Medical Limited
Manufacturer SRN: GB-MF-000025649
UDI-DI: 05039139000990
Basic UDI-DI: 5039139TF025QA
Reference: 30PENPLAS
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

koplight light handle

koplight light handle and its accessories

Class IMDR 2017/745On the marketActive device

Manufacturer: Yasui Co., Ltd.
Manufacturer SRN: JP-MF-000010113
UDI-DI: 04562231091074
Basic UDI-DI: 456223109lighthandleY3
Reference: KG-1
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

LAM III Series

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: International Group medical technology and electronics GmbH
Manufacturer SRN: DE-MF-000025679
UDI-DI: 04255716700034
Basic UDI-DI: 42557167IGLAMIIIXQ
Reference: LAM III Series
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:29

Manufacturer products View details

LAM II Series

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: International Group medical technology and electronics GmbH
Manufacturer SRN: DE-MF-000025679
UDI-DI: 04255716700027
Basic UDI-DI: 42557167IGLAMIIPC
Reference: LAM II Series
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:29

Manufacturer products View details

Lichtleitkabel für medizinische Anwendung

Class IMDR 2017/745On the marketDirect marking

Manufacturer: PRINZ Photonics GmbH
Manufacturer SRN: DE-MF-000005212
UDI-DI: 04251823310005
Basic UDI-DI: 42518233KLL01100140V3
Reference: Lichtleitkabel Grundtyp 2
EMDN: Z12010780
EMDN description: SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:23

Manufacturer products View details

Kopfleuchtensystem Binner

Kopfleuchtensystem

Class IMDR 2017/745On the marketDirect marking

Manufacturer: PRINZ Photonics GmbH
Manufacturer SRN: DE-MF-000005212
UDI-DI: 04251823391004
Basic UDI-DI: 42518233KLS01000150ZS
Reference: KLS Binner
EMDN: Z12010799
EMDN description: SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:23

Manufacturer products View details

LEE - Examination Lights (including Portegra)

LEE

Class IMDR 2017/745On the market

Manufacturer: MAVIG GmbH
Manufacturer SRN: DE-PR-000020388
UDI-DI: 04251339900844
Basic UDI-DI: 4251339900448W3
Reference: LE5217100
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

LEO-Surgical Lights (including Portegra)

LEO

Class IMDR 2017/745On the market

Manufacturer: MAVIG GmbH
Manufacturer SRN: DE-PR-000020388
UDI-DI: 04251339900233
Basic UDI-DI: 4251339900455VY
Reference: LE70044-GE
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

ATMOS HL 21 LED

Headlights

Class IMDR 2017/745On the marketActive device

Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG
Manufacturer SRN: DE-MF-000005570
UDI-DI: 04250365149876
Basic UDI-DI: 42503651ENTVisHL21P9
Reference: 506.7551.0
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:20

Manufacturer products View details

CURVLIGHT MAX

CURVLIGHT

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Wieth Medical Systems e.K.
Manufacturer SRN: DE-MF-000019163
UDI-DI: 04170000050285
Basic UDI-DI: 417000005028headlight5L
Reference: 1011.01
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:35

Manufacturer products View details

MedLED Spectra, Bezel only, G8

Class INot specifiedOn the market

Manufacturer: KLS Martin SE & Co. KG
Manufacturer SRN: DE-MF-000005551
UDI-DI: 04067118019757
Basic UDI-DI: 40576052635J
Reference: 17-510-82-04
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:06

Manufacturer products View details

00810021436951

LIGHT

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DCI International, LLC
Manufacturer SRN: US-MF-000022306
UDI-DI: 00810021436951
Basic UDI-DI: 081002143lightKD
Reference: LIGHT
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

SOL20-3-V

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Scanatron AG
Manufacturer SRN: CH-MF-000013600
UDI-DI: 07649991941126
Basic UDI-DI: 7649991941SOLSF
Reference: 20.3000.000
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: Scanatron International NL
Last updated: 29.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

06979909985005

Class IMDR 2017/745On the marketActive device

Manufacturer: Fepdon (Nanjing) Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000057056
UDI-DI: 06979909985005
Basic UDI-DI: 697990998SOL00174
Reference: EZ5000D
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Ireland
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 28.07.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details