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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 5 of 15

Device	Model / Reference	Registries	Class	Status
Mouth Piece, 13M	AD0028	EUDAMED	Class IIa	Active
HC Norman Mask Elbow (22M/15F-15M	XTA0138	EUDAMED	Class IIa	Active
Connector, 22F, 15M, K Resin	AC0142	EUDAMED	Class IIa	Active
Connector, 15M, 7.5F, PP	AC0155	EUDAMED	Class IIa	Active
C22 Star Lumen Tubing, 200cm, 6M	AO0063	EUDAMED	Class IIa	Active
Water Trap, 22M	AB0100	EUDAMED	Class IIa	Active
EVA Hose, 22F, 150cm	AT0051	EUDAMED	Class IIa	Active
PLS Valve, 10cmH2O, 22F	AN0019	EUDAMED	Class IIa	Active
Y Connector w/port , 22/15mm, 22M	AC0129	EUDAMED	Class IIa	Active
Hytrel Hose, 22F/22T, 90cm, Blue	AT0062	EUDAMED	Class IIa	Active
Hi-Oxygen Mask(Child)	XMR0009	EUDAMED	Class IIa	Active
Silicone Mask, #5	AM0007	EUDAMED	Class IIa	Active
IPPB Circuit, Universal	AB0127	EUDAMED	Class IIa	Active
Silicone mask, size 1, infant large	XMR0016	EUDAMED	Class IIa	Active
PEEP Valve, 5~20cmH2O, 22F	AV0038	EUDAMED	Class IIa	Active
Adult Aerosol Face with O2 Nipple	XTA0024	EUDAMED	Class IIa	Active
Smooth bore oxygen tubing 2.1 metres	XTA0018	EUDAMED	Class IIa	Active
Silicone mask, size 4, adult	XMR0106	EUDAMED	Class IIa	Active
Silicone Circuit, Adult, 120cm	AB0040	EUDAMED	Class IIa	Active
NebEasy Nebulizer Mask Child with mask, nebulizer chamber, tubing PVC, (DEHP-free)	XTF0005	EUDAMED	Class IIa	Active
Silicone Breathing Bag, 0.5L	XMR0044	EUDAMED	Class IIa	Active
nAPV Circuit w/Pressure Port	AN0029	EUDAMED	Class IIa	Active
Silicone Breathing Bag, 3L w/Loop End	AB0109	EUDAMED	Class IIa	Active
Aircushion mask, size 4, adult	XMR0102	EUDAMED	Class IIa	Active
NIV Mask, L	AM0001	EUDAMED	Class IIa	Active
LDS3 Catheter Mount, 15F, 22/15mm	AB0045	EUDAMED	Class IIa	Active
MHC One Way Valve (22F to 22M)	XTA0133	EUDAMED	Class IIa	Active
Water Trap, 15M, Amber	AB0112	EUDAMED	Class IIa	Active
BH-3 Bubble Humidifier	AH0027	EUDAMED	Class IIa	Active
MDI Adaptor, 22F, 22M	AD0031	EUDAMED	Class IIa	Active
Paediatric Venturi Mask Kit Air	XTA0071	EUDAMED	Class IIa	Active
Silicone Breathing Bag, 3L	XMR0049	EUDAMED	Class IIa	Active
Silicone breathing hose, child/infant,	XMR0012	EUDAMED	Class IIa	Active
Y Connector, 15F, 10M, 6M	AC0032	EUDAMED	Class IIa	Active
Open Cuff Silicone Face Mask #0	XAM0001	EUDAMEDFDA UDI	Class IIa	Active
nMask, 35mm	AN0040	EUDAMED	Class IIa	Active
Silicone Circuit, Adult, 120cm	AB0058	EUDAMED	Class IIa	Active
Water Trap, 15M	AB0110	EUDAMED	Class IIa	Active
Sil.Flex Mask, #2	AM0016	EUDAMED	Class IIa	Active
NIV mask, large, including headgear	XMR0028	EUDAMED	Class IIa	Active
Softip-1 Nasal Cannula, Adult	AO0150	EUDAMED	Class IIa	Active
L Connector, 7.6M, Luer, PC	AC0093	EUDAMED	Class IIa	Active
Paediatric Nebulizer Kit	XTA0081	EUDAMED	Class IIa	Active
TC-1 Hose Clip, 15F w/3 clips	AB0102	EUDAMED	Class I	Active
Reusable elbow connector, 22M/15F, 22F	XMR0055	EUDAMED	Class IIa	Active
R7 Resuscitator, Infant w/Mask	AR0070	EUDAMED	Class IIa	Active
Aircushion mask, Size 5, Adult Large	XMR0026	EUDAMED	Class IIa	Active
Silicone Breathing Bag, 1L w/Loop End	AB0108	EUDAMED	Class IIa	Active
Auto Chamber, Infant	AH0038	EUDAMED	Class IIa	Active
nBonnet, #5/XL, Black	AN0009	EUDAMED	Class I	Active

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