Manufacturer

Hugemed

ChinaLegal entities : Shenzhen HugeMed Medical Technical Development Co., Ltd.

Markets : Germany · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 8 · class I, II · latest in 2026 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

9 categories, 16 models including 16 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Video processors	Z12020406	HugeMed HUV-02 HugeMed MS-8 HugeMed VLM-02,VLM-032 refs HUV-01	IIa MDR	EUDAMED record Report an error
Video laryngoscopes	Z12021004	HT2,HT3,HT4,HT M3,HT M4,HT P2,HT ML03 refs HugeMed VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT3 refs MAC 1,MAC 2,MAC 3,MAC 4,MAC 5,MILLER 00,MILLER 0,MILLER 1,MAC D1,MAC D2,MAC D3,MAC D4,MAC D53 refs	I MDR	EUDAMED record Report an error
Choledocoscopes	Z12020501	CH-M52,CH-M52H2 refs HugeMed CL-A、CL-B2 refs	IIa MDR	EUDAMED record Report an error
Uteroscopes	Z12020709	HU32 HugeMed HU30,HU30S,HU30M2 refs	IIa MDR	EUDAMED record Report an error
Bronchoscopes	Z12020801	BR-M58,BR-M52,BR-M50,BR-M40,BR-M32,BR-M25,BR-M22,BR-M58H,BR-M52H,BR-M40H3 refs	IIa MDR	EUDAMED record Report an error
Cystoscopes	Z12020701	CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H3 refs	IIa MDR	EUDAMED record Report an error
Endoscope transport carts	Z12029003	MT-01,MT-022 refs	I MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	HugeMed SA01	I MDR	EUDAMED record Report an error
Video hysteroscopes	Z12020712	HugeMed HY-45A, HY-45B, HY-50A, HY-50B3 refs	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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