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Oxy2Mask O2/ETCO2

OK-2125-8

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Southmedic Inc.
Manufacturer SRN: CA-MF-000005669
UDI-DI: 10620974003127
Basic UDI-DI: 6209741423242142BL
Reference: OK-2125-8SLM
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

NHF Prong Kit, #2

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980114045
Basic UDI-DI: 69239801ND2MBPL
Reference: AO0174
EMDN: R0301020302
EMDN description: HIGH FLOW THERAPY NASAL CANNULAS (HFNC)
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

EVA Circuit, Infant, 120cm w/2WT

Disposable Ventilation Circuit

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980105197
Basic UDI-DI: 69239801ND2SBQ6
Reference: AB0269
EMDN: R02010102
EMDN description: BREATHING CIRCUITS, WITH WATER TRAP
First on market country: Cyprus
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-205 ME Dryer With Male Slip Luer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106905607
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-205
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-209 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106900695
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-209
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-225 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106903726
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-225
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-226 DATEX 12" ME W/ 1/16" BARBS

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106906123
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-226
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-227 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106902361
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-227
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-229 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106906192
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-229
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

BRAUN Intense Pulsed Light (IPL)

Intense pulsed light equipment for hair removal, Annex XVI

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Cyden Limited
Manufacturer SRN: UK-MF-000039581
UDI-DI: 08006530698689
Basic UDI-DI: 506035278IPL0144
Reference: A9212
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-228 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106902170
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-228
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-241 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106900053
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-241
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-243 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106900107
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-243
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-245 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106900008
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-245
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-49

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106901210
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-49
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-249 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106903221
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-249
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-253 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106901838
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-253
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-254 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106900473
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-254
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-255 24" ME W/ MALE SLIP AND BARB

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106905430
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-255
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

ME-050-03-261 Nafion Dryer

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Perma Pure, LLC
Manufacturer SRN: US-MF-000003962
UDI-DI: 00840106901579
Basic UDI-DI: 08401069MESeriesJA
Reference: ME-050-03-261
EMDN: R9080
EMDN description: RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 24.09.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details