Identity
- Trade Name
- STERLINK™ FDA UDI
- Generic Name
- Hydrogen peroxide device sterilant FDA UDI
- Device Name
- sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group of sterilant cassette products which are designed to be used only by STERLINK™ sterilizer products, low temperature plasma sterilization system. The STERLOAD is supposed to be inserted in the STERLINK™ chamber to proceed sterilization process. FDA UDI
- Model / Reference
- STERLOAD EUDAMEDFDA UDISTERMATE EUDAMED
- Description
- sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group of sterilant cassette products which are designed to be used only by STERLINK™ sterilizer products, low temperature plasma sterilization system. The STERLOAD is supposed to be inserted in the STERLINK™ chamber to proceed sterilization process. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500030 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800066500030 EUDAMED
- 510(k) Number
- K212200 FDA UDI
- FDA Product Code
- MLR FDA UDI
- EMDN Code
- S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
- GMDN Term
- Hydrogen peroxide device sterilant FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sterlink™ by Plasmapp Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd.
Sources (2)
- FDA UDI b17b6c2b-43a4-4a31-a274-a1cc65d94a51 36 fields · synced Jul 8, 2026
- EUDAMED 49a38312-60c8-4aa7-91e4-02e898528925 61 fields · synced Jun 10, 2026