Pure Global
230123
II
current

Cystoscopes膀胱镜

This profile provides complete Hong Kong MDACS registration information for Cystoscopes. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Cystoscopes

產品資訊: 膀胱镜

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11112
Product Code Detail
11112 Cystoscopes
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (製造商)
LiNA Medical Aps
Lina Medical Aps
Formervangen 5, 2600 GLOSTRUP DENMARK
前者 5, 2600 格洛斯特鲁普 丹麦
Authorised Representative (AR)
Keymax Technology (Hong Kong) Ltd.
启盈科技 (香港) 有限公司
31508289
Regulatory Timeline
Registration Date
April 06, 2023
Expiry Date
April 06, 2028
Product Models
LiNA OperaScope with HDMI cable & LCD (OP-201-6), LiNA OperaScope Recording Module (OPRM1), LiNA OperaScope Rat Tooth Alligator Grasper (OP-GRA-6), LiNA OperaScope Biopsy Forceps (OP-FCP-6), LiNA OperaScope Scissors (OP-SCI-3), LiNA OperaScope Tubing & Drape Kit (OP-TDK-6), LiNA OperaScope Lasso (OP-LAS10-3, OP-LAS16-3), LiNA Operascope with HDMI cable (OP-200-6)
LiNA OperaScope,带HDMI电缆和LCD(OP-201-6),LiNAOperaScope记录模块(OPRM1),LiNA OperaScope大鼠齿鳄鱼抓取器(OP-GRA-6),LiNAOperaScope活检钳(OP-FCP-6),LiNAOperaScope剪刀(OP-SCI-3),LiNAOperaScope管和悬垂套件(OP-TDK-6),LiNA OperaScope Lasso(OP-LAS10-3,OP-LAS16-3),LiNA操作镜,带HDMI电缆(OP-200-6)