Identity
- Trade Name
- Sample cup EUDAMEDSample Cups FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- Sample Cups .5ML EUDAMEDCups, .5ML Sample CX, LX, DX EUDAMED
- Model / Reference
- IL-06799200D EUDAMEDBK-651412D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403015566 EUDAMED00811403011711 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301IL06799200D6C EUDAMED081140301BK651412DDK EUDAMED
- EMDN Code
- W05020180 SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES EUDAMED
- GMDN Term
- Assay container IVD, single-use 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sample cup 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 | 081140301IL06799200D6C | 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 (3)
- EUDAMED 5bf56fcc-e26a-4e3c-b94a-76b29dbe0a83 61 fields · synced Jul 22, 2026
- EUDAMED ebd649c0-969c-4279-99b6-cbb8fcf6c792 61 fields · synced May 18, 2026
- FDA UDI b27af843-e707-42e4-9e1d-6887ee5fa103 32 fields · synced May 29, 2026