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DxH 500 Series Cleaner
EUDAMEDFDA UDIClass A (EU MDR)
Ref B36868Model DxH 500 Series Cleaner
Identity
- Trade Name
- DxH 500 Series Cleaner EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- DxH 500 Series Cleaner EUDAMEDFDA UDI
- Model / Reference
- DxH 500 Series Cleaner EUDAMEDB36868 EUDAMEDFDA UDI
- Description
- DxH 500 Series Cleaner FDA UDI
Identifiers
- Catalog Number
- B36868 FDA UDI
- Primary DI / UDI-DI
- 15099590671877 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902HEMCLEANERYY EUDAMED
- FDA Product Code
- JCB FDA UDI
- EMDN Code
- W0202010185 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
DxH 500 Series Cleaner 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 | 150995902HEMCLEANERYY | 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 9691f6b9-60bb-4c29-98ee-8ddc6177496c 61 fields · synced Jul 9, 2026
- FDA UDI 8c637df2-6bc8-491a-9d72-3c1fb0d6d0c1 35 fields · synced May 30, 2026