Identity
- Trade Name
- Iris Diluent EUDAMEDIris® FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- Iris Diluent EUDAMEDIris® Diluent Pack (NA) FDA UDI
- Model / Reference
- Iris Diluent EUDAMED800-3202 EUDAMEDDiluent (NA) FDA UDI
- Description
- Iris® Diluent Pack (NA) FDA UDI
Identifiers
- Catalog Number
- 800-3202 FDA UDI
- Primary DI / UDI-DI
- 10837461002239 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902UADILUENTMY EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W02039085 VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Iris Diluent by Beckman Coulter Ireland Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902UADILUENTMY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED f9805af3-aef0-4ce7-b0fc-b8f814632bd5 61 fields · synced Jun 18, 2026
- FDA UDI 207029eb-6eb5-4370-af75-f6682ab5d06f 34 fields · synced May 30, 2026