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06975380920160

25040

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ningbo Risenmed Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041539
UDI-DI: 06975380920160
Basic UDI-DI: 697538092250405E
Reference: 160*210mm-gold and silver
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

Temperature Management System

TC-200,TC-150,TC-100

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062334
Basic UDI-DI: 6970341680111201GL
Reference: TC-200
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Emergency Blanket

Class IMDR 2017/745On the market

Manufacturer: Zhuozhou Huanuo Life-Saving Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000054282
UDI-DI: 06940181416204
Basic UDI-DI: 694018140783EA
Reference: 2030mm×1270mm
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Finland
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 10:23

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Female drain hose coupling

HICO-Polyurethane-Water pads

Class IMDR 2017/745On the marketDirect marking

Manufacturer: pfm medical hico GmbH
Manufacturer SRN: DE-MF-000012921
UDI-DI: 04042301216762
Basic UDI-DI: 4042301Z1204ADVZ
Reference: 550077
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:02

Manufacturer products View details

Equipotential bonding cable 1m

Hypo-/ hyperthermia systems

Class IMDR 2017/745On the marketDirect marking

Manufacturer: pfm medical hico GmbH
Manufacturer SRN: DE-MF-000012921
UDI-DI: 04042301209054
Basic UDI-DI: 4042301Z1204ACVX
Reference: 592905
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:02

Manufacturer products View details

HICO-Hose extension

HICO-Polyurethane-Water pads

Class IMDR 2017/745On the marketActive device

Manufacturer: pfm medical hico GmbH
Manufacturer SRN: DE-MF-000012921
UDI-DI: 04042301205827
Basic UDI-DI: 4042301Z1204ABVV
Reference: 550022
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:02

Manufacturer products View details

HICO-Aquatherm 660

Hypo-/ hyperthermia systems

Class IIbMDR 2017/745On the marketActive device

Manufacturer: pfm medical hico GmbH
Manufacturer SRN: DE-MF-000012921
UDI-DI: 04042301205773
Basic UDI-DI: 4042301Z1204AAVT
Reference: 590001
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:02

Manufacturer products View details

Cocoon

CWS 5000

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

Manufacturer: Care Essentials Pty Ltd
Manufacturer SRN: AU-MF-000009150
UDI-DI: 09332017002007
Basic UDI-DI: 09332017CWS5HB
Reference: CWS 5000
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Bulgaria
Authorised representative: Advena Limited
Last updated: 01.07.2026 11:11

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Cocoon

CWS 4000

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

Manufacturer: Care Essentials Pty Ltd
Manufacturer SRN: AU-MF-000009150
UDI-DI: 09332017000553
Basic UDI-DI: 09332017CWS4H9
Reference: CWS 4000
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Bulgaria
Authorised representative: Advena Limited
Last updated: 01.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

CureWrap®

CureWraps

Class IMDR 2017/745On the marketSingle use

Manufacturer: Belmont Medical Technologies
Manufacturer SRN: US-MF-000007062
UDI-DI: 07290012127175
Basic UDI-DI: 08961280020000128J
Reference: 500-03500
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.07.2026 11:06

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Thermal Accideng Blacket

Emergency Rescue Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ningbo Pinmed Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000008488
UDI-DI: 06970879337450
Basic UDI-DI: 697087933PM12053PF
Reference: PM12053
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emergency Rescue Blanket

Class IMDR 2017/745On the market

Manufacturer: Ningbo Pinmed Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000008488
UDI-DI: 06970879330376
Basic UDI-DI: 697087933PM12053PF
Reference: PM12053
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Emergency Rescue Blanket

Class IMDR 2017/745On the market

Manufacturer: Ningbo Pinmed Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000008488
UDI-DI: 06970879330185
Basic UDI-DI: 697087933PM12053PF
Reference: PM12053
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

WiseCuddler

Patient Warming System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Harbin BOOYUN Medical Instrument Co.,Ltd.
Manufacturer SRN: CN-MF-000042837
UDI-DI: 06970721781295
Basic UDI-DI: 697072178PWCTN
Reference: HPTC-101
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Italy
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm Paediatric Full Body Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043338
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2002
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm Upper Body Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043345
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2003
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm Lower Body Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043352
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2004
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm Tube Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043369
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2007
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm Paediatric Underbody Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043383
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2009
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Snuggle Warm, Small Upper Body Convective Warming Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043390
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2010
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: -
Authorised representative: ICU Medical BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details