Manufacturer

Endoso

ChinaLegal entities : Hunan Endoso Life Technology Co., Ltd

Markets : Germany · Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 3 · class I, II · latest in 2025 · see on the FDA website

EU representative : Umedwings Netherlands B.V. (Netherlands)

10 categories, 18 models including 18 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories	Z12020480	F1、F22 refs HD2000-C1、HD2000-C1-N2 refs P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E3 refs P2-F1、P2-F2、P2-F3、P2-F4、P2-G1、P2-G2、P2-G3、P2-G4、P2-H1、P2-H2、P2-H3、P2-H4、P2-I1、P2-I2、P2-I3、P2-I4、P2-J1、P2-J2、P2-J3、P2-J4、P2-K1、P2-K2、P2-K3、P2-K4、P2-L1、P2-L2、P2-L3、P2-L4、P2-M1、P2-M2、P2-M3、P2-M43 refs R600-A、R600-B、R600-C、R600-D3 refs 1 other U400、U400-A 、U400-B 、U400-C、U400-D 、U500 、U500-A 、U500-B3 refs	I MDR	EUDAMED record Report an error
Laparoscopes	Z12029009	4KA0,4KA0R,4KA30,4KA30R,4KA45, 4KA45R3 refs Laparoscope 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R13 refs	I, IIa MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	HL2000-L1 、HL2000-L1-N、HL5000-L1 、HL5000-L1-N3 refs LR600-A、LR600-B、LR600-C、LR600-D3 refs	I MDR	EUDAMED record Report an error
Video processors	Z12020406	P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E3 refs VLS-A	I, IIa MDR	EUDAMED record Report an error
Bioimaging viewing monitors	Z11900802	M-32W、M-32B、M-32C3 refs	I MDR	EUDAMED record Report an error
Bronchoscopes	Z12020801	BC12-1、BC12-2、BC20-1、BC20-2、BC22-1、BC22-2、BC22-3、BC28-1、BC28-2、BC28-33 refs	IIa MDR	EUDAMED record Report an error
Endoscope transport carts	Z12029003	PTC-1,PTC-2,PTC-3,YTC-1,YTC-2,YTC-3,ECT-13 refs	I MDR	EUDAMED record Report an error
Nephroscopes	Z12020705	PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S23 refs	IIa MDR	EUDAMED record Report an error
Video choledocoscopes	Z12020507	PCH12-1, PCH12-2, PCH12-3, PCH22-1, PCH22-2, PCH22-3, PCH22-4, PCH22-5, PCH22-6, PCH24-1, PCH24-2, PCH24-3, PCH24-4, PCH24-5, PCH24-63 refs	IIa MDR	EUDAMED record Report an error
Video cystourethroscopes	Z12020711	PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-63 refs	IIa MDR	EUDAMED record Report an error

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