gudid
Primary ID: C7563-90
Pointe Scientific CK-MB (UDI C7563-90)
Manufactured by HORIBA INSTRUMENTS INCORPORATED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Pointe Scientific CK-MB - Primary ID C7563-90
Device Regulatory Overview
The Pointe Scientific CK-MB (Model/Catalog Number: C7563-90) is a medical device manufactured by HORIBA INSTRUMENTS INCORPORATED. This product is indexed under FDA Product Code / Category Classification JHW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- C7563-90
- Product Code / EMDN
- JHW
- Device Name
- Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only.
- Database Sync Date
- 2026-08-09 09:22:13
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Pointe Scientific CK-MB?
The registered manufacturer of record for Pointe Scientific CK-MB is HORIBA INSTRUMENTS INCORPORATED.
What is the Primary UDI-DI identifier for Pointe Scientific CK-MB?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is C7563-90.
What classification code is assigned to this device?
This device is registered under product classification code JHW.
Similar Classification Devices (JHW)
Other Devices by HORIBA INSTRUMENTS INCORPORATED
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint