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Qingdao Hightop Biotech Co., Ltd.

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Complete regulatory portfolio for Qingdao Hightop Biotech Co., Ltd. in China's medical device market. This registrant has 182 medical devices registered with China NMPA, with registrations dating from Feb 14, 2017 to Jan 03, 2025.

Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.

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NMPA Official Data
182 Devices
Company Overview
Total Devices
182
Province/Region
Shandong
ๅฑฑไธœ
Address
No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
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Registration Timeline
Earliest Approval
Feb 14, 2017
Latest Approval
Jan 03, 2025
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DJ Fang

DJ Fang

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Device Class Distribution
Breakdown of 182 devices by regulatory classification
Class II
148
81.3% of total
Class III
34
18.7% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Product NameClassRegistration NumberApproval DateExpiry DateDetail
ๅฟƒ่‚Œ่‚Œ้’™่›‹็™ฝI/่‚Œ้…ธๆฟ€้…ถๅŒๅทฅ้…ถ/่‚Œ็บข่›‹็™ฝ่”ๅˆๆฃ€ๆต‹่ฏ•ๅ‰‚็›’(ๅนฒๅผๅ…็–ซ่งๅ…‰ๅ‘ๅ…‰ๆณ•)
ๅฟƒ่‚Œ่‚Œ้’™่›‹็™ฝI/่‚Œ้…ธๆฟ€้…ถๅŒๅทฅ้…ถ/่‚Œ็บข่›‹็™ฝ่”ๅˆๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅนฒๅผๅ…็–ซ่งๅ…‰ๅ‘ๅ…‰ๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242401060
Jan 03, 2025
Dec 01, 2029
่‚บ็‚Ž่กฃๅŽŸไฝ“IgGๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’(ๅ…็–ซ่งๅ…‰ๆณ•)
่‚บ็‚Ž่กฃๅŽŸไฝ“IgGๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅ…็–ซ่งๅ…‰ๆณ•๏ผ‰
Class III
ๅ›ฝๆขฐๆณจๅ‡†20243402486
Dec 13, 2024
Dec 12, 2029
Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method)
่„‚่›‹็™ฝ็›ธๅ…ณ็ฃท่„‚้…ถA2ๆต‹ๅฎš่ฏ•ๅ‰‚็›’๏ผˆ่ƒถไนณๅ…็–ซๆฏ”ๆตŠๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242401055
Dec 02, 2024
Dec 01, 2029
่‚บ็‚Žๆ”ฏๅŽŸไฝ“IgMๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’(ๅ…็–ซ่งๅ…‰ๆณ•)
่‚บ็‚Žๆ”ฏๅŽŸไฝ“IgMๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅ…็–ซ่งๅ…‰ๆณ•๏ผ‰
Class III
ๅ›ฝๆขฐๆณจๅ‡†20243402367
Nov 21, 2024
Nov 20, 2029
่‚บ็‚Žๆ”ฏๅŽŸไฝ“IgGๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’(ๅ…็–ซ่งๅ…‰ๆณ•)
่‚บ็‚Žๆ”ฏๅŽŸไฝ“IgGๆŠ—ไฝ“ๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅ…็–ซ่งๅ…‰ๆณ•๏ผ‰
Class III
ๅ›ฝๆขฐๆณจๅ‡†20243402368
Nov 21, 2024
Nov 20, 2029
ฮฒ-Hydroxybutyrate Assay Kit (ฮฒ-Hydroxybutyrate Dehydrogenase Method)
ฮฒ-็พŸไธ้…ธๆต‹ๅฎš่ฏ•ๅ‰‚็›’๏ผˆฮฒ-็พŸไธ้…ธ่„ฑๆฐข้…ถๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242401023
Nov 19, 2024
Nov 18, 2029
Lipoprotein-associated phospholipase A2 assay kit (enzymatic)
่„‚่›‹็™ฝ็›ธๅ…ณ็ฃท่„‚้…ถA2ๆต‹ๅฎš่ฏ•ๅ‰‚็›’๏ผˆ้…ถๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242400885
Sep 23, 2024
Sep 22, 2029
Pepsinogen I./Pepsinogen II./Gastrin 17 Combined Detection Kit (Dry Immunofluorescence Luminescence Method)
่ƒƒ่›‹็™ฝ้…ถๅŽŸโ… /่ƒƒ่›‹็™ฝ้…ถๅŽŸโ…ก/่ƒƒๆณŒ็ด 17่”ๅˆๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅนฒๅผๅ…็–ซ่งๅ…‰ๅ‘ๅ…‰ๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242400891
Sep 23, 2024
Sep 22, 2029
Homocysteine Assay Kit (Dry Immunofluorescence Luminescence)
ๅŒๅž‹ๅŠ่ƒฑๆฐจ้…ธๆฃ€ๆต‹่ฏ•ๅ‰‚็›’๏ผˆๅนฒๅผๅ…็–ซ่งๅ…‰ๅ‘ๅ…‰ๆณ•๏ผ‰
Class II
้ฒๆขฐๆณจๅ‡†20242400802
Aug 14, 2024
Aug 13, 2029
Fully automatic fluorescence immunoassay analyzer
ๅ…จ่‡ชๅŠจ่งๅ…‰ๅ…็–ซๅˆ†ๆžไปช
Class II
้ฒๆขฐๆณจๅ‡†20242220740
Jul 25, 2024
Jul 11, 2029