Identity
- Trade Name
- IRIS EUDAMEDFDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- iQ Body Fluids Conical Tubes EUDAMEDThe tubes are specimen receptacles for urine. The plastic test tubes are 16 x 100 mm and contain 250 per package. FDA UDI
- Model / Reference
- 800-3215 EUDAMED660-3021 EUDAMEDFDA UDI
- Description
- The tubes are specimen receptacles for urine. The plastic test tubes are 16 x 100 mm and contain 250 per package. FDA UDI
Identifiers
- Catalog Number
- 660-3021 FDA UDI
- Primary DI / UDI-DI
- 10837461001065 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902DXUACCESSORYDM EUDAMED
- Unit of Use DI
- 00837461001068 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W050301020102 SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES EUDAMED
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 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
No
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Iris 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 | 150995902DXUACCESSORYDM | 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 9f833b20-ab98-499d-8ca5-c5c3013f8c89 61 fields · synced Jun 18, 2026
- FDA UDI 7c9a7b01-7c0a-4a73-a17d-67d796e2b624 35 fields · synced May 30, 2026