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Bittium MedicalSuite Center

MedicalSuite Center v3.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221028
Basic UDI-DI: 643003522SuiteCYA
Reference: S0000022661
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

Medixine Suite 9.0

Medixine Suite

Class IIaMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: Medixine Oy
Manufacturer SRN: FI-MF-000002552
UDI-DI: 06429830089704
Basic UDI-DI: 64298300897MXSuiteT8
Reference: Medixine Suite 9.0
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:47

Manufacturer products View details

Lumoral protective plastic cover

Class IMDR 2017/745On the marketSingle use

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197283
Basic UDI-DI: 6429810197Plasticcover7J
Reference: 60
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumorinse

Class IIaMDR 2017/745On the market

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197207
Basic UDI-DI: 6429810197Lumorinsetabl4P
Reference: N/A
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Junior

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197191
Basic UDI-DI: 6429810197LumoralJunioB8
Reference: 21
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Clinic

03, 13

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197184
Basic UDI-DI: 6429810197LumoralClini66
Reference: 03, 13
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Treatment

01, 11

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197153
Basic UDI-DI: 6429810197LumoralTreatmP6
Reference: 01, 03
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral Junior

Class IMDR 2017/745On the market

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197085
Basic UDI-DI: 6429810197LumoralJuniorP7
Reference: 21
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

Lumoral

10000mAh

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Koite Health Oy
Manufacturer SRN: FI-MF-000006901
UDI-DI: 06429810197030
Basic UDI-DI: 6429810197LumoralPowerbQ7
Reference: N/A
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:38

Manufacturer products View details

CVN Arctic Pallas Hypothermia Bag

H5000

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CVN medical Oy
Manufacturer SRN: FI-MF-000032554
UDI-DI: 06429810144133
Basic UDI-DI: 6429810144H5000QW
Reference: H5000-5016P
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

HESS! Kullancskiszedő kanál

Kullancskiszedő

Class IMDR 2017/745On the market

Manufacturer: Elysium Laboratories Kft.
Manufacturer SRN: HU-MF-000039543
UDI-DI: 05999862705398
Basic UDI-DI: 5999862705TCK01S5
Reference: 10021
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

Puregraft 50

50/Pure

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Bimini Health Tech
Manufacturer SRN: US-MF-000008649
UDI-DI: 00850034511122
Basic UDI-DI: 085003451150/PUREAA
Reference: 50/PURE
EMDN: Z12040214
EMDN description: LIPOSUCTION SYSTEMS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

MANUALEX PRO

MANUALEX

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Sanimed Jarosław Jędrzejowski
Manufacturer SRN: PL-MF-000051705
UDI-DI: 05906168035623
Basic UDI-DI: 59061680356MANUALEXC8
Reference: MANUALEX-PRO
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

CarnaLife Holo

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: MEDAPP SPÓŁKA AKCYJNA
Manufacturer SRN: PL-MF-000029453
UDI-DI: 05904978657028
Basic UDI-DI: 5904978657CLHJV
Reference: 05904978657028
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:57

Manufacturer products View details

AngioExpert

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Angionica sp. z o.o.
Manufacturer SRN: PL-MF-000020079
UDI-DI: 05904844679802
Basic UDI-DI: 59048446798AngioExpertH5
Reference: 1
EMDN: Z12040111
EMDN description: BLOOD FLOW METERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:56

Manufacturer products View details

CALMEAN Senior Band

Class IMDR 2017/745On the marketActive device

Manufacturer: CAMO CODE SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000046325
UDI-DI: 05904610750544
Basic UDI-DI: 590461075CALMEAN-S-BANDXF
Reference: L16
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:48

Manufacturer products View details

Dermatoscopes

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000019086
UDI-DI: 05904507277758
Basic UDI-DI: 590450727DM13AV
Reference: 20.000.901
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:43

Manufacturer products View details

SiDLY VITAL CARE

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: SIDLY SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000027229
UDI-DI: 05903890760069
Basic UDI-DI: 59038907600OPASKAVCHE
Reference: 5903890760069
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:09

Manufacturer products View details

SiDLY Care PRO

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SIDLY SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000027229
UDI-DI: 05903890760045
Basic UDI-DI: 59038907600OpaskiCB
Reference: 5903890760045
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:09

Manufacturer products View details

‌‌S‌eismofit Sensor

200

Class IMDR 2017/745On the marketDirect marking

Manufacturer: VentriJect ApS
Manufacturer SRN: DK-MF-000040899
UDI-DI: 05744006575012
Basic UDI-DI: 574400657seissensor01MM
Reference: 200
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:39

Manufacturer products View details