Identity
- Trade Name
- Digital Electrocardigraph FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Model / Reference
- E30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932562310157 FDA UDI
- 510(k) Number
- K131858 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiograph, professional, multichannel
Digital Electrocardigraph by Guangdong Biolight Meditech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd.
Sources (1)
- FDA UDI 3581432e-5a75-4950-a8a6-21a2231258b5 33 fields · synced May 30, 2026