Identity
- Trade Name
- Tropocells FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Model / Reference
- 06212SC FDA UDI
Identifiers
- Catalog Number
- 06212SC FDA UDI
- Primary DI / UDI-DI
- 17290015874202 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tropocells by Estar Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
BK110035 also covers:
- Eclipse PRP, Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells — ESTAR TECHNOLOGIES LTD
- Tropocells®, Eclipse PRP, Healeon PRP — ESTAR TECHNOLOGIES LTD
- Tropocells®, Eclipse PRP, Healeon PRP — ESTAR TECHNOLOGIES LTD
- Eclipse PRP HC — Eclipse, Inc.
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
- Estar Technologies Ltd
Sources (1)
- FDA UDI 287559fe-f44d-42ad-93aa-9b9878f09913 36 fields · synced Jun 1, 2026