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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 12 of 15

Device	Model / Reference	Registries	Class	Status
Test Lung, 1L	AB0001	EUDAMED	Class I	Active
Diverter Cap w/Valve, 30F	AV0049	EUDAMED	Class IIa	Active
Coaxial Circuit, Adult, 1.5m	AB0468	EUDAMEDFDA UDI	Class IIa	Active
Adult Disposable Resuscitator	XTA0009	EUDAMED	Class IIa	Active
PEP Aircushion Mask, M	AM0181	EUDAMED	Class IIa	Active
tHME, 15F	AH0023	EUDAMED	Class IIa	Active
OM-3 Mask, Adult w/Tubing	AO0083	EUDAMED	Class IIa	Active
Flow Indicator w/tubing, 200cm	AO0030	EUDAMED	Class IIa	Active
HMEF w/Luer, 22F/15M, 22/15mm	AH0041	EUDAMED	Class IIa	Active
Rescu-7 Reservoir Bag, 2500ml	AR0086	EUDAMED	Class IIa	Active
OM-2 Mask, Child w/Tubing	AO0151	EUDAMED	Class IIa	Active
L Connector, 22F, 22M	AC0016	EUDAMED	Class IIa	Active
Air-Soft Mask Size 3 Child Large	XTA0105	EUDAMED	Class IIa	Active
Connector, 15M, 10M, PP	AC0045	EUDAMED	Class IIa	Active
Y Connector w/Luer, 15F, 10M	AC0034	EUDAMED	Class IIa	Active
Adult Resuscitator with PEEP Valve	XTA0128	EUDAMED	Class IIa	Active
Airsoft Mask, #3 w/Valve	AM0029	EUDAMED	Class IIa	Active
Rendell Baker Silicone Mask, #2	AM0021	EUDAMED	Class IIa	Active
Nasal CPAP Mask, 15M, L w/Durable Headge	AM0065	EUDAMED	Class IIa	Active
EVA Circuit, Adult, 180cm (SY)	AB0185	EUDAMED	Class IIa	Active
OM-2 Mask, Adult	AO0086	EUDAMED	Class IIa	Active
OM-4 Trachea Mask, Adult w/Tubing	AO0106	EUDAMED	Class IIa	Active
NIV mask, small, including headgear	XMR0074	EUDAMED	Class IIa	Active
MR-100 Reservoir Bag, 600ml	AR0020	EUDAMED	Class IIa	Active
BH-1 Bubble Humidifier, 6PSI	AH0035	EUDAMED	Class IIa	Active
Connector, 22F, 22F, PC	AC0057	EUDAMED	Class IIa	Active
Durable Straight Connector 22F, 22F	XTA0135	EUDAMED	Class IIa	Active
L Connector , 22/15mm, 15M, 6M	AC0024	EUDAMED	Class IIa	Active
CV-3 Manifold w/L6M	AV0034	EUDAMED	Class IIa	Active
Disposable Tubing & hose	AT0036	EUDAMED	Class IIa	Active
nCannula, #6 w/nBonnet	AN0026	EUDAMED	Class IIa	Active
nCannula Kit, #0&1	AN0062	EUDAMED	Class IIa	Active
Coaxial-D Circuit, Adult, 180cm	AB0181	EUDAMED	Class IIa	Active
EVA SB Hose, 22F, 180cm	AT0031	EUDAMED	Class IIa	Active
Filter, 22F/15M, 22/15mm w/Luer	AF0006	EUDAMED	Class IIa	Active
OM-3 Mask, Adult w/Tubing	AO0154	EUDAMED	Class IIa	Active
Jackson Reese Circuit Complete	XKO0007	EUDAMED	Class IIa	Active
Connector, 22/19mm, 13M, PP	AC0052	EUDAMED	Class IIa	Active
ET Tube Connector 15M, 3.5F	XTA0041	EUDAMED	Class IIa	Active
nCPAP Prong, #7 w/ Pressure Port Elbow	AN0017	EUDAMED	Class IIa	Active
SP Connector, 22/15mm, 15M, Luer	AC0196	EUDAMED	Class IIa	Active
Reusable Silicone Mask Size: 3	XTA0099	EUDAMED	Class IIa	Active
Adj. PEEP Valve, 5~20cmH2O	AV0002	EUDAMED	Class IIa	Active
Silicone Hose, 17T, 90cm w/Cuff 22Fx2	AT0013	EUDAMED	Class IIa	Active
Connector, 22F, 15M, PSF	AC0135	EUDAMED	Class IIa	Active
CV-1 Manifold	AV0005	EUDAMED	Class IIa	Active
Cap w/strap 7.6F, 10F	AC0012	EUDAMED	Class IIa	Active
AM-2 Aerosol Mask, Child	AD0068	EUDAMED	Class IIa	Active
Oxygen Mask Adult	XTF0008	EUDAMED	Class IIa	Active
Adult aerosol mask - with tubing	XTA0090	EUDAMED	Class IIa	Active

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