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Irygator Sanity AIDA LUX

Class IMDR 2017/745On the market

Manufacturer: Albert Polska Sp. z o.o.
Manufacturer SRN: PL-MF-000007130
UDI-DI: 05907438940111
Basic UDI-DI: 59074389105UW
Reference: 4010312250000
EMDN: Z12019007
EMDN description: IRRIGATORS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:21

Manufacturer products View details

Dual Action Pump - Hand Variant

URO 058

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Calyx Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000038787
UDI-DI: 05906168942228
Basic UDI-DI: 59061689422URO058LG
Reference: URO 058
EMDN: Z12019007
EMDN description: IRRIGATORS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

Dual Action Pump (Foot Variant)

URO 057

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Calyx Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000038787
UDI-DI: 05906168942211
Basic UDI-DI: 59061689422URO057LE
Reference: URO 057
EMDN: Z12019007
EMDN description: IRRIGATORS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

WARMQUBE S Version: D

WARMQUBE Chamber heater

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Prolab spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000036482
UDI-DI: 05905745684001
Basic UDI-DI: 5905745684WARMQUBERS
Reference: PRO-WQ-S-D-001
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:08

Manufacturer products View details

LiNA SkinHook

SH-110-NS; SH-220-NS

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: LiNA Medical AG
Manufacturer SRN: CH-MF-000046832
UDI-DI: 05708265017669
Basic UDI-DI: 57082651019-2NSMB
Reference: SH-110-NS
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Denmark
Authorised representative: LiNA Medical Polska Sp. z o.o.
Last updated: 31.07.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

LiNA SeaStar

4000-S-Q, 4000-S-SL, 4000-S-SS, 4000-S-VL, 4000-S-VS, 4000-S-VV

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: LiNA Medical AG
Manufacturer SRN: CH-MF-000046832
UDI-DI: 05708265017300
Basic UDI-DI: 57082651019-1SRP
Reference: 4000-S-Q
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Denmark
Authorised representative: LiNA Medical Polska Sp. z o.o.
Last updated: 31.07.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

LiNA SeaStar

4000-R-SL, 4000-R-SS, 4000-R-VL, 4000-R-VS, 4000-R-VV;

Class IMDR 2017/745On the market

Manufacturer: LiNA Medical AG
Manufacturer SRN: CH-MF-000046832
UDI-DI: 05708265017614
Basic UDI-DI: 57082651019-12B
Reference: 4000-R-SL
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Denmark
Authorised representative: LiNA Medical Polska Sp. z o.o.
Last updated: 31.07.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

LiNA SkinHook

LiNA Skin Hook

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: LiNA Medical AG
Manufacturer SRN: CH-MF-000046832
UDI-DI: 05708265017201
Basic UDI-DI: 57082651019-22D
Reference: SH-110
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Denmark
Authorised representative: LiNA Medical Polska Sp. z o.o.
Last updated: 31.07.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

Airglove Sleeves

Patient Warming System

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: Airglove Medical Ltd
Manufacturer SRN: UK-MF-000048008
UDI-DI: 05061072880025
Basic UDI-DI: 506107288AirgloveBL
Reference: GL501
EMDN: Z12019008
EMDN description: BLOOD HEATERS
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Maxi Air

MAS000001-DE

Class IMDR 2017/745On the marketActive device

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05055982794510
Basic UDI-DI: 5060693520297WS
Reference: MAS000001-DE
EMDN: Z12019010
EMDN description: PATIENT TRANSFER SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 08:51

Manufacturer products View details

Alpha Active 3

648305BG

Class IIaMDR 2017/745On the marketActive device

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05055982780919
Basic UDI-DI: 5060693520020VD
Reference: 648305DK
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 08:51

Manufacturer products View details

metra Liver Perfusion Circuit

D0146

Class IIaMDR 2017/745On the marketContains latexSingle useSterile

Manufacturer: OrganOx Ltd
Manufacturer SRN: GB-MF-000031421
UDI-DI: 05060462240029
Basic UDI-DI: 506046224PerfusionCircCJ
Reference: D0146
EMDN: Z12019002
EMDN description: EQUIPMENT FOR THE TRANSPORT OF ORGANIC MATERIAL
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

Smoke Set

Gas Filters

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120955999
Basic UDI-DI: 506012095Cat379
Reference: 2200/47BBKBTUA001/0001
EMDN: Z12019004
EMDN description: SURGICAL SMOKE EVACUATION SYSTEMS
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 31.07.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

extriCARE® Negative Pressure Wound Therapy Pump

extriCARE® 1000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alleva Medical Limited
Manufacturer SRN: CN-MF-000018963
UDI-DI: 04897089070323
Basic UDI-DI: 489708907MI388KZ
Reference: MI388
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 31.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

extriCARE® Negative Pressure Wound Therapy Pump

extriCARE® 3000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alleva Medical Limited
Manufacturer SRN: CN-MF-000018963
UDI-DI: 04897089070309
Basic UDI-DI: 489708907MI391KN
Reference: MI391
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 31.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

Carilex

Negative Pressure Wound Therapy System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CARILEX MEDICAL, INC
Manufacturer SRN: TW-MF-000002145
UDI-DI: 04713616090841
Basic UDI-DI: 471987369S1XXXRV
Reference: S1001-0033
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

EZ-410

Anti-Slip Swivel Positioning Turner

Class IMDR 2017/745On the market

Manufacturer: EZ-Care Solution, Co., Ltd.
Manufacturer SRN: TW-MF-000028166
UDI-DI: 04717048510342
Basic UDI-DI: 471704851EZ-3003E
Reference: EZ-410
EMDN: Z12019010
EMDN description: PATIENT TRANSFER SYSTEMS
First on market country: Austria
Authorised representative: AF Pharma Service Europe SL
Last updated: 31.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Carilex

Negative Pressure Wound Therapy System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CARILEX MEDICAL, INC
Manufacturer SRN: TW-MF-000002145
UDI-DI: 04713616090216
Basic UDI-DI: 471987369S1XXXRV
Reference: S1002-0012
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Irrigation Pump

IP Series

Class IIaMDR 2017/745On the market

Manufacturer: Lagis Enterprise Co., Ltd.
Manufacturer SRN: TW-MF-000007081
UDI-DI: 04714123021939
Basic UDI-DI: 471412302IP-01TH
Reference: IP-1000
EMDN: Z12019007
EMDN description: IRRIGATORS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Imaging Projection System

MIPS

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mitaka Kohki Co., Ltd.
Manufacturer SRN: JP-MF-000013028
UDI-DI: 04589698450589
Basic UDI-DI: 458969845058QK
Reference: MIPS
EMDN: Z12019099
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER
First on market country: Poland
Authorised representative: Mitaka Europe GmbH
Last updated: 31.07.2026 06:18

Manufacturer products Authorised representative products Authorised representative actors View details