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Tropocells

FDA UDI

Class II (US FDA UDI)

by Estar Technologies Ltd

Identity

Trade Name
Tropocells FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Model / Reference
1253VTSF10 FDA UDI

Identifiers

Catalog Number
1253VTSF10 FDA UDI
Primary DI / UDI-DI
07290015874229 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

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

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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Estar Technologies Ltd

Sources (1)

  • FDA UDI 68c5cc12-aa79-4b36-9939-728a733b28d6 36 fields · synced Jun 6, 2026