Unimicro Medical Systems (Shenzhen) Co., Ltd.
Medical device makerAI in ChinaAI. FDA records under its name, each linked to the record.
- Records across the group: 7, 2 entitiesAI
- 510(k) clearances: 5
- Warning letters: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Unimicro Medical Systems (Shenzhen) Co., Ltd. and its 1 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 18, 2023 | Warning letter: Medical DevicesCDRH | Warning letters |
| Jan 6, 2022 | Warning letter: Sterility assurance, Process validation, CAPACDRH | Warning letters |
| Aug 10, 2015 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless TrocarK141594 · GCJ | 510(k) clearances |
| Jul 31, 2015 | Unimicro Veress NeedleK150068 · HIF | 510(k) clearances |
| Apr 13, 2015 | Monopolar Laparascopic AccessoriesK142208 · GEI | 510(k) clearances |
| Nov 13, 2014 | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCHK141593 · GCJ | 510(k) clearances |
| Aug 4, 2014 | UNIMICRO SUCTION IRRIATION TUBING SETK141592 · GCJ | 510(k) clearances |
Subsidiaries and Divisions
1 firms in the Unimicro Medical Systems (Shenzhen) Co., Ltd. group, most records firstCanada and Imports
Across the Unimicro Medical Systems (Shenzhen) Co., Ltd. group, matched by company name- Active Health Canada device licences
- 15, as of Nov 10, 2026
Names and Identifiers
- Appears as
- FEI numbers in warning letters
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built