Smilecare

GUDID 06937579913902

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD, calibrator

• Primary Device ID: 06937579913902
• NIH Device Record Key: c7159683-eca1-41b9-9d2d-37834e9fa988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smilecare
• Version Model Number: HCG-S3
• Company DUNS: 654510689
• Company Name: NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
• Device Count: 3
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937579913858 [Primary]
GS1	06937579913902 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123050

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [Smilecare]

• 06937579913919: LH -S50
• 06937579913902: HCG-S3