Identity
- Trade Name
- HemaPrep FDA UDI
- Generic Name
- Blood smearing manual instrument IVD FDA UDI
- Device Name
- Semi-Automated Blood Smearing Device FDA UDI
- Model / Reference
- XU-10012-01 FDA UDI
- Description
- Semi-Automated Blood Smearing Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350040976753 FDA UDI
- FDA Product Code
- GKJ FDA UDI
- GMDN Term
- Blood smearing manual instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.5850 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood smearing manual instrument IVD
HemaPrep by Cellavision AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood smearing manual instrument IVD.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- HEMODROP BLOOD DISPENSER — Biomedical Polymers, Inc. · Class I
- HemaPrep — Cellavision AB · Class I
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
- Cellavision AB
Sources (1)
- FDA UDI b5ed9edd-7af5-444e-ae66-9985342b750a 33 fields · synced Jun 8, 2026