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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 9 of 15

Device	Model / Reference	Registries	Class	Status
HMEF, 22F/15M, 22/15mm	AH0025	EUDAMED	Class IIa	Active
Extension Hose, 24cm, 22F, 22M	AT0010	EUDAMED	Class IIa	Active
Venturi, 40% O2, 22F, Red	AO0052	EUDAMED	Class IIa	Active
Silicone breathing hose, adult, 1.5m	XMR0011	EUDAMED	Class IIa	Active
Water Trap, 15M	AB0324	EUDAMED	Class IIa	Active
Sil.Flex-2 Mask, #3	AM0023	EUDAMEDFDA UDI	Class IIa	Active
Sil.Flex Hose, 22F, 140cm	AB0141	EUDAMED	Class IIa	Active
Aircushion mask, size 2, Child	XMR0023	EUDAMED	Class IIa	Active
Connector, 22F, 10/7.6mm, K Resin	AC0041	EUDAMED	Class IIa	Active
Air-soft Mask Size 1 Infant Large	XTA0103	EUDAMED	Class IIa	Active
Reusable Silicone Mask Size: 5	XTA0101	EUDAMED	Class IIa	Active
Airsoft Mask, #2 w/Valve	AM0028	EUDAMED	Class IIa	Active
CPAP Face Mask Set w/Hose, L	AM0120	EUDAMEDFDA UDI	Class IIa	Active
CPR Super Mask	XTA0123	EUDAMED	Class IIa	Active
Silicone Mask, #5	AM0018	EUDAMED	Class IIa	Active
EVA Circuit, Child, 150cm	AB0289	EUDAMED	Class IIa	Active
Oxi.Plus Nasal Cannula Set, #0	AO0040	EUDAMED	Class IIa	Active
T Connector , 22F, 22/18mm, 22M, 6M	AC0165	EUDAMED	Class IIa	Active
Collapsible Hose, 22F, 180cm	AT0055	EUDAMED	Class IIa	Active
Bain Circuit, 120cm	AB0229	EUDAMED	Class IIa	Active
EVA Hose, 15F, 15cm	AT0052	EUDAMED	Class IIa	Active
OM-3 HiO2 Mask, Child w/Tubing, PVC Bag	AO0097	EUDAMED	Class IIa	Active
EVA Circuit, infant	AB0160	EUDAMED	Class IIa	Active
Airsoft Mask, #0	AM0025	EUDAMED	Class IIa	Active
nCannula, #0 w/nBonnet	AN0020	EUDAMED	Class IIa	Active
Breathing Bag, 1L, Latex	AB0104	EUDAMED	Class IIa	Active
Open Cuff Silicone Face Mask #5	XAM0006	EUDAMEDFDA UDI	Class IIa	Active
Sil.Plus Circuit, Child w/2 Water Trap	AB0037	EUDAMEDFDA UDI	Class IIa	Active
NIF Filtration Valve	AP0003	EUDAMED	Class I	Active
BH-1 Bubble Humidifier, 2PSI	AH0028	EUDAMED	Class IIa	Active
LV-2 Valve, 19M	AV0025	EUDAMED	Class IIa	Active
Cap w/Strap 4.3M, Green	AC0209	EUDAMED	Class IIa	Active
OM-3 Oxygen Mask, Adult	AO0081	EUDAMED	Class IIa	Active
Silicone Head Harness Large	XTA0001	EUDAMED	Class I	Active
Fixed Venturi Mask	XTF0010	EUDAMED	Class IIa	Active
SP Connector, 22/15mm, 15M, 7.6F	AC0062	EUDAMED	Class IIa	Active
Mhc Disp. Adjustable Peep Valve	XTA0124	EUDAMED	Class IIa	Active
Jackson Reese Circuit Open Tail Bag 0.5L	XKO0034	EUDAMED	Class IIa	Active
Y Connector, 15F, 15Mx2, 4.3F, PC	AC0035	EUDAMED	Class IIa	Active
Silicone mask, size 3, child large	XMR0105	EUDAMED	Class IIa	Active
MR-100 Plus Resuscitator set, adult	AR0059	EUDAMED	Class IIa	Active
Headgear for CPAP Mask, L, Silicone	AM0014	EUDAMED	Class I	Active
nMask, 25mm	AN0038	EUDAMED	Class IIa	Active
High Concentration Mask	XTA0069	EUDAMED	Class IIa	Active
EVA Circuit, Adult, 1.5m	AB0264	EUDAMED	Class IIa	Active
Trachea Tee Set, w/Tubing	AO0058	EUDAMED	Class IIa	Active
AM-3 Aerosol Mask, Adult	AD0067	EUDAMED	Class IIa	Active
Silicone Hose, 17T, 150cm w/Cuff 22Fx2	AT0014	EUDAMED	Class IIa	Active
EVA Catheter Mount, 15cm, 22F	AB0197	EUDAMED	Class IIa	Active
Connector, 15M, 6.5F, PP	AC0153	EUDAMED	Class IIa	Active

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