Identity
- Trade Name
- Cuvette EUDAMEDReaction Cuvettes FDA UDI
- Generic Name
- Multichannel clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Reaction Cuvettes H911 EUDAMED
- Model / Reference
- BM-7170551D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403012688 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301BM7170551DMA EUDAMED
- EMDN Code
- W05020180 SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES EUDAMED
- GMDN Term
- Multichannel clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary 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
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
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
Cuvette by DIAMOND DIAGNOSTICS 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 | 081140301BM7170551DMA | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (2)
- EUDAMED fc90334f-c22c-4866-aca6-c5d83aa81584 61 fields · synced Jul 13, 2026
- FDA UDI 5d3f4149-bea9-482e-8d97-33de7bf75659 32 fields · synced May 29, 2026