Identity
- Trade Name
- Lexa MINI RIS-303 EUDAMEDFDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- TABLE-TOP STEAM STERILIZER LEXA MINI RIS-303 FDA UDI
- Model / Reference
- 38671 EUDAMED19944212 EUDAMEDLexa MINI RIS-303 FDA UDI
- Description
- TABLE-TOP STEAM STERILIZER LEXA MINI RIS-303 FDA UDI
Identifiers
- Catalog Number
- 19944210 FDA UDI
- Primary DI / UDI-DI
- +E308199442120 EUDAMEDE308199442100 FDA UDI
- Basic UDI-DI
- ++E30838671HP EUDAMED
- FDA Product Code
- FLE FDA UDI
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Steam sterilizer
Lexa MINI RIS-303 by W & H Sterilization Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K223858 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W & H Sterilization Srl
Sources (2)
- FDA UDI c3e90b27-d77a-4682-a428-a3405f18dd77 35 fields · synced Jul 10, 2026
- EUDAMED df569861-8679-4693-b25b-cde747b92159 61 fields · synced Jul 10, 2026