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STEAMPlus Sterilization Integrator
EUDAMEDFDA UDIClass I (EU MDR)
Ref SSI-100Model Chemical Indicators
Identity
- Trade Name
- STEAMPlus Sterilization Integrator EUDAMEDFDA UDI
- Generic Name
- Chemical/physical sterilization process indicator FDA UDI
- Device Name
- Wicking-style device that verifies when all critical parameters of steam sterilization have been met during a sterilizer cycle. FDA UDI
- Model / Reference
- Chemical Indicators EUDAMEDSSI-100 EUDAMEDFDA UDI
- Description
- Wicking-style device that verifies when all critical parameters of steam sterilization have been met during a sterilizer cycle. FDA UDI
Identifiers
- Catalog Number
- SSI-100 FDA UDI
- Primary DI / UDI-DI
- 10732224710355 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224ChemIndicator6N EUDAMED
- Unit of Use DI
- 00732224710358 EUDAMED
- FDA Product Code
- JOJ FDA UDI
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Chemical/physical sterilization process indicator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
STEAMPlus Sterilization Integrator by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224ChemIndicator6N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 27692fdf-a19d-4031-8f2a-7affaeebeb8c 61 fields · synced Jun 8, 2026
- FDA UDI 19c39960-3172-446d-961d-95647b4af4f3 36 fields · synced May 30, 2026