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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 6 of 15

Device	Model / Reference	Registries	Class	Status
EVA hose 22F cuff, L=30 metres (100FT)	XTA0084	EUDAMED	Class IIa	Active
Replacement Valve for Concord Mask	XTA0036	EUDAMED	Class IIa	Active
Aerosol Face Tent	XTA0075	EUDAMED	Class IIa	Active
EVA Catheter Mount, 15cm, 22/15mm	AB0149	EUDAMED	Class IIa	Active
(10)Flex Trach Adapt 15cm, 22M/15F-15M	XRE0008	EUDAMED	Class IIa	Active
Spacer Mask, #4	AM0088	EUDAMED	Class IIa	Active
Bain Circuit, 180cm	AB0230	EUDAMED	Class IIa	Active
R7 Resuscitator, Adult, w/Mask	AR0011	EUDAMED	Class IIa	Active
CPAP Silent Vent, Swivel	AC0106	EUDAMED	Class IIa	Active
Paed Nebuliser Kit W/O Tubing	XTA0089	EUDAMED	Class IIa	Active
NHF Prong Kit, #3	AO0010	EUDAMED	Class IIa	Active
Gas Sampling Line M-M 10 feet/3.0 metres	XTA0012	EUDAMED	Class IIa	Active
Rendell Baker Silicone Mask, #0	AM0019	EUDAMED	Class IIa	Active
Paediatric Soft Nasal Cannula With	XTA0061	EUDAMED	Class IIa	Active
Jackson Reese Circuit Open Tail Bag 1L	XKO0035	EUDAMED	Class IIa	Active
Oxygen Mask Pediatric	XTF0007	EUDAMED	Class IIa	Active
Silicone Breathing Bag, 1L	XMR0045	EUDAMED	Class IIa	Active
Silicone Single Limb Circuit, Adult	AB0028	EUDAMED	Class IIa	Active
Adult oxygen mask medium conc.	XTA0048	EUDAMED	Class IIa	Active
Air-Soft Mask Size 0, Infant	XTA0102	EUDAMED	Class IIa	Active
PEP Aircushion Mask, L	AM0036	EUDAMED	Class IIa	Active
EVA Hose, 22F, 180cm	AT0012	EUDAMED	Class IIa	Active
nMask, 40mm	AN0041	EUDAMED	Class IIa	Active
Neb.Easy AM-1 Mask, Adult w/Tube	AD0050	EUDAMED	Class IIa	Active
Tail-end control valve	AB0328	EUDAMED	Class IIa	Active
Mouth Piece 22mmID	XTA0013	EUDAMED	Class IIa	Active
PEEP Valve, 2.5~10cmH2O, 30F	AV0019	EUDAMED	Class IIa	Active
Bacterial Filter	XMR0014	EUDAMED	Class IIa	Active
LDS1 Catheter Mount, SL15F, 22F	AB0032	EUDAMED	Class IIa	Active
Kink-Free Green Oxygen Tubing 7.5 Metres	XTA0065	EUDAMED	Class IIa	Active
Silicone Flex Tube, 14cm, 22F, 10F	AB0136	EUDAMEDFDA UDI	Class IIa	Active
SBC Child Breathing Circuit	XMR0078	EUDAMED	Class IIa	Active
Adult Venturi Mask Kit Air Entrainment	XTA0070	EUDAMED	Class IIa	Active
Hydrophobic Filter, 7.6M w/Luer	AF0003	EUDAMED	Class IIa	Active
Open Cuff Silicone Face Mask #2	XAM0003	EUDAMEDFDA UDI	Class IIa	Active
OM-2 HiO2 Mask, Child w/Tubing, PVC Bag	AO0156	EUDAMED	Class IIa	Active
Disposable respiratory circuit 2.0m	XMR0033	EUDAMED	Class IIa	Active
Jackson Rees Circuit w/Bag-0.5L	AB0023	EUDAMED	Class IIa	Active
CV-3 manifold w/L22M	AV0096	EUDAMED	Class IIa	Active
Adult Nasal Cannula With Tubing	XTA0059	EUDAMED	Class IIa	Active
SP Connector, 22F, 22/15mm, Luer, PSF	AC0207	EUDAMED	Class IIa	Active
Disposable Resuscitator Neonate	XTA0096	EUDAMED	Class IIa	Active
Kink-Free Oxygen Tubing 4.2 Metres	XTA0064	EUDAMED	Class IIa	Active
Kink-Free Oxygen Tubing 3 Metres	XTA0068	EUDAMED	Class IIa	Active
AM-4 Trachea Mask, Adult	AO0006	EUDAMED	Class IIa	Active
Manifold, 2 Way, PSF	AV0078	EUDAMED	Class IIa	Active
Flow Meter Adaptor, White	AO0076	EUDAMED	Class IIa	Active
Open Cuff Silicone Face Mask #4	XAM0005	EUDAMEDFDA UDI	Class IIa	Active
Filter, 22F/15M, 22/15mm	AF0007	EUDAMED	Class IIa	Active
Reusable wye connector, 22M	XMR0058	EUDAMED	Class IIa	Active

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