HealthyWiser

GUDID 16970429840147

Co-Innovation Biotech Co., Ltd

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 16970429840147
• NIH Device Record Key: 344c8f9a-522e-4495-acb2-6ce0338021a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthyWiser
• Version Model Number: HCG Test Strip
• Company DUNS: 421302978
• Company Name: Co-Innovation Biotech Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970429840133 [Primary]
GS1	06970429840140 [Package]; Contains: 06970429840133; Package: [50 Units]; In Commercial Distribution
GS1	16970429840147 [Package]; Contains: 06970429840140; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-31

Devices Manufactured by Co-Innovation Biotech Co., Ltd

• 16970429841342 - DTPM: 2023-12-18
• 16970429841632 - DTPM: 2023-12-18
• 16970429840154 - HCG TEST STRIP: 2023-07-06
• 16970429840178 - co-innovation: 2023-05-08
• 16970429841816 - co-innovation: 2022-11-21 Rapid Multi-drug Test Cup
• 16970429841441 - co-innovation: 2022-01-24 14P Drug Test
• 16970429841533 - co-innovation: 2022-01-24 15P Drug Test
• 16970429841625 - co-innovation: 2022-01-24 16P Drug Test