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GaleMed (Xiamen) Co., Ltd.

China·CN-MF-000020627

Last updated September 17, 2026

Information

Country: China
Address: Xiamen Area of China (Fujian) Pilot Free Trade Zone, , Xiamen, China
Website: www.galemed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jeann Wang
EUDAMED SRN: CN-MF-000020627
FDA FEI Number: 3006783791
DUNS Number: —

Catalogue (737)

Page 4 of 15

Device	Model / Reference	Registries	Class	Status
Open Cuff Silicone Face Mask #1	XAM0002	EUDAMEDFDA UDI	Class IIa	Active
Reusable Silicone Mask Size: 4	XTA0100	EUDAMED	Class IIa	Active
BREATHING BAG 1L with Cuff	XTA0130	EUDAMED	Class IIa	Active
LDS2 Catheter Mount, L15F, 22F	AB0048	EUDAMED	Class IIa	Active
MR-100 Resuscitator set, infant	AR0002	EUDAMED	Class IIa	Active
Y Connector, 15F, 15M	AC0017	EUDAMED	Class IIa	Active
Softip-1 Nasal Cannula, Infant	AO0066	EUDAMED	Class IIa	Active
Adult Oxygen Mask Bulk Packed Med.	XTA0046	EUDAMED	Class IIa	Active
nMask, 45mm	AN0042	EUDAMED	Class IIa	Active
nMask, 50mm	AN0043	EUDAMED	Class IIa	Active
Electrostatic Breathing Filter ID22/OD15	XHM0011	EUDAMED	Class IIa	Active
Cap w/Strap, for 7.6F Taper Port	AC0072	EUDAMED	Class IIa	Active
Neb.Easy AM-2 Mask, Child w/Tube	AD0058	EUDAMED	Class IIa	Active
NIV mask, middle, including headgear	XMR0030	EUDAMED	Class IIa	Active
MR-100 Plus Resuscitator, Infant	AR0062	EUDAMED	Class IIa	Active
Latex-Free Breathing Bag 2L	XMR0053	EUDAMED	Class IIa	Active
L Connector, 4.3M, 4M	AC0113	EUDAMED	Class IIa	Active
Air-Soft Mask Size 6 w/valve	XTA0122	EUDAMED	Class IIa	Active
EMS Circuit w/Mask, PEEP Valve	AB0070	EUDAMED	Class IIa	Active
AM-1 Aerosol Mask, Infant	AD0064	EUDAMED	Class IIa	Active
Adult Resuscitator w/o Pop-off	XTA0005	EUDAMED	Class IIa	Active
CPAP Face Mask Set w/Hose, S	AM0122	EUDAMEDFDA UDI	Class IIa	Active
Filter, 22F/15M, 22M/15F w/Luer	AF0020	EUDAMED	Class IIa	Active
EVA smooth bore hose 22F cuff, L= 60 cm	XTA0086	EUDAMED	Class IIa	Active
Reusable breathing circuit	XMR0043	EUDAMED	Class IIa	Active
Gas Sampling Line, 450cm, 4M	XKO0038	EUDAMED	Class IIa	Active
Nebuliser Mouthpiece Kit	XTA0082	EUDAMED	Class IIa	Active
Filter, HEPA w/luer, 22F/15M, 22/15mm	AF0002	EUDAMED	Class IIa	Active
OM-1 HiO2 Mask, Adult w/Tubing	AO0089	EUDAMED	Class IIa	Active
Flow Meter Adaptor Extended, Green	AO0074	EUDAMED	Class IIa	Active
AM-2 Venturi Mask, Adult	AO0102	EUDAMED	Class IIa	Active
Neonate Anesthesia Circuit 180cm	XKO0015	EUDAMED	Class IIa	Active
CV-3 Manifold w/6B	AV0001	EUDAMED	Class IIa	Active
Neonate Soft Nasal Cannula With Tubing	XTA0062	EUDAMED	Class IIa	Active
CPAP Exhale Vent, 22M, 22M	AC0019	EUDAMED	Class IIa	Active
Swivel Wye Connector 22M	XTA0139	EUDAMED	Class IIa	Active
SP Connector, 22F, 22M, 6M	AC0006	EUDAMED	Class IIa	Active
MIP/MEP Kit	AP0005	EUDAMED	Class I	Active
nBonnet, #3/M, Red	AN0007	EUDAMED	Class I	Active
Connector, 15M, 6M, PP	AC0138	EUDAMED	Class IIa	Active
Peak flow Meter, 800 LPM	AL0012	EUDAMED	Class I	Active
nHME, 15F, 15M	AH0022	EUDAMED	Class IIa	Active
CV-3 Manifold, L22M	AB0020	EUDAMED	Class IIa	Active
MHC Aerosol Tee Connector	XTA0134	EUDAMED	Class IIa	Active
T Connector, 22M, 22/15mm, 22M	AC0167	EUDAMED	Class IIa	Active
Water Trap, 22M, Amber	AB0113	EUDAMED	Class IIa	Active
C2 Tubing Adaptor, 6F, PVC	AO0117	EUDAMED	Class IIa	Active
Adult Adjustable Venturi Mask	XTA0056	EUDAMED	Class IIa	Active
EVA smooth bore hose 22F cuff, L= 180 cm	XTA0087	EUDAMED	Class IIa	Active
Paediatric Tracheostomy Mask	XTA0077	EUDAMED	Class IIa	Active

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