Identity
- Trade Name
- iQ Lamina EUDAMEDiQ®200 FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- iQ Lamina EUDAMEDiQ® Lamina™ Case of 2 x 7 L FDA UDI
- Model / Reference
- iQ Lamina EUDAMED800-3236 EUDAMEDiQ® Lamina™ Case of 2 x 7 L FDA UDI
- Description
- iQ® Lamina™ Case of 2 x 7 L FDA UDI
Identifiers
- Catalog Number
- 800-3236 FDA UDI
- Primary DI / UDI-DI
- 10837461002376 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902UALAMINA39 EUDAMED
- FDA Product Code
- PPM 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
- 864.4010 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
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
iQ Lamina 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 | 150995902UALAMINA39 | 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 7698683d-9b36-472d-9bbf-9fe2464016b1 61 fields · synced Oct 7, 2026
- FDA UDI e49febeb-c123-43e7-bcb3-fb9c5be2bc92 34 fields · synced May 30, 2026