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SMART M-CELL PRP Concentration System BSC+3 60

by Miracell Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809286201031 UDI-DI Date16 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SMART M-CELL PRP Concentration System
Generic Name
Haematological concentrate system preparation kit, platelet concentration
Model / Reference
BSC+3 60
Primary DI / UDI-DI
08809286201031
510(k) Number
FDA Product Code
QBV
GMDN Term
Haematological concentrate system preparation kit, platelet concentration
Device Class
Class I
Regulation Number
862.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250516)

Other devices from Miracell Co., Ltd.

See all devices from Miracell Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No