Identity
- Trade Name
- Sample probe EUDAMEDFDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Sample Probe AU EUDAMED
- Model / Reference
- OY-MU9934D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403017126 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301OYMU9934DTX EUDAMED
- EMDN Code
- W05020180 SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES EUDAMED
- GMDN Term
- Multiple 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sample probe 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 | 081140301OYMU9934DTX | 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 a6f77f4b-2bd3-4a1a-ae45-cc0ac0e972b0 61 fields · synced Aug 2, 2026
- FDA UDI 14dc9d3e-eba5-4f9a-9915-257b32d7e9b3 32 fields · synced May 30, 2026