Identity
- Trade Name
- STERLINK™ FDA UDI
- Generic Name
- Biological sterilization indicator reader FDA UDI
- Device Name
- Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals. FDA UDI
- Model / Reference
- Mini-bio FDA UDI
- Description
- Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500221 FDA UDI
- 510(k) Number
- K212193 FDA UDI
- FDA Product Code
- FRC FDA UDIJOJ FDA UDI
- GMDN Term
- Biological sterilization indicator reader FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator reader
Sterlink™ by Plasmapp Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biological sterilization indicator reader.
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- Attest™ — 3M COMPANY · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Celerity — STERIS CORPORATION · Class II
- Stryker — TERRAGENE S.A. · Class II
- BIOTRACE™ — TERRAGENE S.A. · Class II
Cleared under the same submission
K212193 also covers:
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
- Plasmapp Co., Ltd.
Sources (1)
- FDA UDI 53be54c6-5a80-49ef-9b8c-7b5807e4a4f5 35 fields · synced Jun 8, 2026