Identity
- Trade Name
- Tubing kit EUDAMEDPinch Valve Tubing Kit FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- Pinch Valve Tubing Kit EUDAMED
- Model / Reference
- AV-BP5012D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403010400 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301AVBP5012D4D EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
- GMDN Term
- Ion-selective analyser IVD 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
No
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
Tubing kit 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 | 081140301AVBP5012D4D | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (2)
- EUDAMED c42abc1b-d5ff-4d0b-950b-8336844225a6 61 fields · synced Jun 18, 2026
- FDA UDI 9c51ee12-89fe-40ce-996a-de1b0e707e74 32 fields · synced May 30, 2026