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TOP Corporation

Japan·JP-MF-000003928

Last updated September 17, 2026

Information

Country: Japan
Address: Hasunuma-cho, 75-1, Itabashi-ku, Tokyo, Japan
Website: global.topcon.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +81 3 3966 3141
PRRC Contact: —
EUDAMED SRN: JP-MF-000003928
FDA FEI Number: 3002808374
DUNS Number: —

Catalogue (172)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
REFRACTION SYSTEM Chronos	Chronos	EUDAMEDFDA UDI	Class I	Active
REFRACTION SYSTEM Chronos	Chronos	EUDAMED	Class I	Active
Auto Refractometer	RM-800	EUDAMEDFDA UDI	Class I	Active
AUTO CHART PROJECTOR ACP-8(Type: EM)	ACP-8 (Type:EM)	EUDAMED	Class I	Active
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus)	470129900	EUDAMED	Class IIa	Active
Slit Lamp Sl-D4 (type Led)	SL-D4 (TYPE LED) with chinrest	EUDAMED	Class I	Active
TOP NEUROPOLE NEEDLE TL 20G 145-10mm	627068	EUDAMED	Class IIa	Active
REFRACTION SYSTEM Chronos	Chronos	EUDAMED	Class I	Active
TOP NEUROPOLE NEEDLE SCC 20G 100-10mm	627262	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE TL 22G 54-4mm	627071	EUDAMED	Class IIa	Active
PuraStat Nozzle System Type E 2.8ch-1600mm	634141	EUDAMED	Class IIa	Active
TOP Spinal Needle 23Gx89mm	C63149	EUDAMED	Class III	Active
TOP NEUROPOLE NEEDLE SC-K 21G 100-10mm	627107	EUDAMED	Class IIa	Active
OPHTHALMIC DATA SYSTEM IMAGEnet 7	IMAGEnet 7	EUDAMED	Class IIa	Active
TOP Endoscopic Hood SHF-070	634121	EUDAMED	Class IIa	Active
PuraStat Nozzle System Type L	634163	EUDAMED	Class IIa	Active
Auto Kerato-Refractometer Kr-800pa	KR-800PA	EUDAMEDFDA UDI	Class I	Active
TOP NEUROPOLE NEEDLE SC-K 22G 100-2mm	E63281	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE SC-K 23G 100-5mm	627112	EUDAMED	Class IIa	Active
AUTO CHART PROJECTOR ACP-8(Type: EM)	ACP-8	EUDAMED	Class I	Active
Slit Lamp Sl-D2	SL-D2 (with chinrest)	EUDAMEDFDA UDI	Class I	Active
Auto Refractometer Rm-800	418469900	EUDAMED	Class I	Active
Trc-Nw400 Non-Mydriatic Retinal Camera	K141481	FDA 510(k)	Class II	Active
5cc Neuraxial Slip Tip Glass Syringe, 5cc Neuraxial Lock Tip Glass Syringe, 5cc Neuraxial Additive Slip Tip Glass Syringe, 10cc Neuraxial Slip Tip Glass Syringe, 10cc Neuraxial Lock Tip Glass Syringe	K182765	FDA 510(k)	Class II	Active
Slit Lamp SL-D301	K161972	FDA 510(k)	Class II	Active
SP-1PSpecular Microscope	K142417	FDA 510(k)	Class II	Active
OPHTHALMIC DATA SYSTEM IMAGEnet 6	IMAGEnet 6	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE TL 20G 145-15mm	627069	EUDAMED	Class IIa	Active
Parallel Binocular Tube Pb-2	PB-2	EUDAMEDFDA UDI	Class I	Active
External Fixation Target Ef-2	EF-2	EUDAMEDFDA UDI	Class I	Active
TOP Endoscopic Hood SHF-040	634116	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE TL 22G 100-5mm	627073	EUDAMED	Class IIa	Active
TOP Syringe 2.5mL Luer Slip Tip	C64213	EUDAMED	Class I	Active
TOP Spinal Needle 20Gx89mm	C63143	EUDAMED	Class III	Active
TOP NEUROPOLE NEEDLE ST 23G 60mm	627083	EUDAMED	Class IIa	Active
Computerized Tonometer Ct-1	416279772	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE XE-PRF 23G 60-5mm	654101	EUDAMED	Class IIa	Active
Pixelchart Pc-50	PC-50	EUDAMED	Class I	Active
TOP Spinal Needle 27Gx89mm	C63153	EUDAMED	Class III	Active
TOP NEUROPOLE NEEDLE ST-P2 23G 130mm	627239	EUDAMED	Class IIa	Active
0°assistant’s Microscope	MS-AM04	EUDAMED	Class I	Active
TOP NEUROPOLE NEEDLE SC-K 20G 150-5mm	627126	EUDAMED	Class IIa	Active
TOP Spinal Needle18G x 89mm	C63141	EUDAMED	Class III	Active
Auto Kerato-Refractometer Kr-1	KR-1	EUDAMEDFDA UDI	Class I	Active
TOP NEUROPOLE NEEDLE RC 22G 100mm	627087	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE TL 20G 145-2mm	627066	EUDAMED	Class IIa	Active
TOP Spinal Needle 25Gx89mm	C63151	EUDAMED	Class III	Active
Slit Lamp Sl-D2	SL-D2 (witout chinrest)	EUDAMEDFDA UDI	Class I	Active
Computerized Tonometer Ct-1	CT-1	EUDAMED	Class IIa	Active
TOP NEUROPOLE NEEDLE BL 20G 145.5-10mm	627104	EUDAMED	Class IIa	Active

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Topcon Corp. US