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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 8 of 15

Device	Model / Reference	Registries	Class	Status
Start-up Kit, Adult, Reusable	XVY0080	EUDAMED	Class IIa	Active
Adult Nebulizer Kit Mask/Bow/tube	XTA0080	EUDAMED	Class IIa	Active
Breathing Bag, 3L, Latex Free	AB0122	EUDAMED	Class IIa	Active
AM-4 Trachea Mask, Child	AO0103	EUDAMED	Class IIa	Active
NebEasy Nebulizer Mask Adult with mask, nebulizer chamber, tubing PVC, (DEHP-free)	XTF0004	EUDAMED	Class IIa	Active
Silicone breathing hose, child/infant	XMR0064	EUDAMED	Class IIa	Active
Reusable Silicone Mask Size: 1	XTA0031	EUDAMED	Class IIa	Active
LDS1 Catheter Mount, SL 15F, 22/15mm	AB0050	EUDAMED	Class IIa	Active
AM-2 Oxygen Mask, Child	AO0101	EUDAMED	Class IIa	Active
CPR-Super Mask	AW0013	EUDAMED	Class IIa	Active
Connector, 15M, 3F, PP	AC0146	EUDAMED	Class IIa	Active
Silicone Circuit, Child 120cm w/2WT	AB0091	EUDAMED	Class IIa	Active
Durable Straight Connector 22M/15F	XMR0083	EUDAMED	Class IIa	Active
Air Cushion Mask MAYO NO:SMHC 2216	XTA0109	EUDAMED	Class IIa	Active
HME w/Tube, 22F, 15F	AH0039	EUDAMED	Class IIa	Active
SP Connector, 22/15mm, 15M, 6M	AC0197	EUDAMED	Class IIa	Active
nCPAP Prong, #3 w/ Pressure Port Elbow	AN0013	EUDAMED	Class IIa	Active
Aircushion mask, size 1, infant large	XMR0021	EUDAMED	Class IIa	Active
SP Connector, 22F, 22/15mm, Luer	AC0066	EUDAMED	Class IIa	Active
Venturi, 28% O2, 22F, Yellow	AO0049	EUDAMED	Class IIa	Active
Softip-1 Nasal Cannula, Child	AO0149	EUDAMED	Class IIa	Active
Disposable Straight connector 15F/18M	XHM0010	EUDAMED	Class IIa	Active
Hi-Oxygen Mask(Adult)	XMR0007	EUDAMED	Class IIa	Active
Paediatric Oxygen Mask High	XTA0072	EUDAMED	Class IIa	Active
Endo Mask, L w/Harness	AW0009	EUDAMED	Class IIa	Active
Coaxial Ckt, Adult, 180cm w/Bag-0.5L	AB0183	EUDAMED	Class IIa	Active
Disposable Resuscitator Paediatric	XTA0098	EUDAMED	Class IIa	Active
LDS1 Catheter Mount, SL 15F, 15M	AB0049	EUDAMED	Class IIa	Active
Paediatric Resuscitator with PEEP Valve	XTA0127	EUDAMED	Class IIa	Active
Paediatric Oxygen Mask	XTA0055	EUDAMED	Class IIa	Active
L Connector, 22F, 22/15mm, PSF	AC0021	EUDAMED	Class IIa	Active
OM-2 HiO2 Mask, Child w/Tubing, PVC Bag	AO0094	EUDAMED	Class IIa	Active
Humidification Chamber, Adult	AH0036	EUDAMED	Class IIa	Active
Connector, 22/15mm, 15M, PP	AC0046	EUDAMED	Class IIa	Active
CPAP Face Mask Set w/Hose, M	AM0121	EUDAMEDFDA UDI	Class IIa	Active
SP Connector, 22/15mm, 22/15mm, Luer	AC0199	EUDAMED	Class IIa	Active
Water Trap, 22M, PSF	AB0111	EUDAMED	Class IIa	Active
Exhalometer filter, 30F, 30M	AF0012	EUDAMED	Class IIa	Active
Bi-level CPAP Mask w/port, L	AM0051	EUDAMED	Class IIa	Active
NebEasy Nebulizer Kit	XTF0003	EUDAMED	Class IIa	Active
Kink-Free Oxygen Tubing 15 Metres	XTA0066	EUDAMED	Class IIa	Active
OM-4 Trachea Mask, Child w/Tubing	AO0104	EUDAMED	Class IIa	Active
Rendell Baker Silicone Mask, #3	AM0022	EUDAMED	Class IIa	Active
Adult Venturiu Mask Kit Air Entrainment	XTA0057	EUDAMED	Class IIa	Active
nCPAP Circuit Set	AN0074	EUDAMED	Class IIa	Active
Silicone Circuit, Child, 120cm	AB0059	EUDAMED	Class IIa	Active
OM-4 Trachea Mask, Adult w/Tubing	AO0105	EUDAMED	Class IIa	Active
Aerosol Tee, 22M, 22/15, 22M Disposable	XTA0043	EUDAMED	Class IIa	Active
Latex-Free Breathing Bag 3L	XMR0081	EUDAMED	Class IIa	Active
BH-2 Bubble Humidifier	AH0034	EUDAMED	Class IIa	Active

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