Identity
- Trade Name
- VISION ESR Analyzer FDA UDI
- Generic Name
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
- Device Name
- Constraint FDA UDI
- Model / Reference
- VISION Pro-C FDA UDI
- Description
- Constraint FDA UDI
Identifiers
- Catalog Number
- V6232 FDA UDI
- Primary DI / UDI-DI
- 06925912710981 FDA UDI
- FDA Product Code
- GKB FDA UDI
- GMDN Term
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.5800 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Erthrocyte sedimentation rate (ESR) analyser IVD
VISION ESR Analyzer by Shenzhen YHLO Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (1)
- FDA UDI f0cf3784-eb8d-4fe8-83b0-ad818068ee70 34 fields · synced Jun 8, 2026