Identity
- Trade Name
- TropoCells FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Model / Reference
- T_PRP11U FDA UDI
Identifiers
- Catalog Number
- T_PRP11U FDA UDI
- Primary DI / UDI-DI
- 07290015874168 FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Radiation Sterilization FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
TropoCells by Estar Technologies Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate system preparation kit, platelet concentration.
- RegenPlasma/RegenKit-Woud Gel-2 — REGEN LAB SA · Class II
- Magellan Complete Disposable Kit — Arteriocyte Medical Systems, Inc.
- Transcend PRP — AEON BIOTHERAPEUTICS CORP. · Class II
- MAXX BMC — ROYAL BIOLOGICS, INC. · Class II
- MAR0Max Convenience kit — Arteriocyte Medical Systems, Inc.
- RegenKit-BCT-3 (20ml)/RegenPlasma — REGEN LAB SA · Class II
- Virtue CPKit — AEON BIOTHERAPEUTICS CORP. · Class II
- Precise Sapphire — Arteriocyte Medical Systems, Inc. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Estar Technologies Ltd
Sources (1)
- FDA UDI 4ca2c703-c0ec-48e0-b91f-ddaddd92cc0c 34 fields · synced Jun 1, 2026