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Syringe
EUDAMEDClass A (EU MDR)
Ref BK-448947DRef BK-467729DRef OY-B16554/1DRef IL-18102002/1
Identity
- Trade Name
- Syringe EUDAMEDSyringe seal EUDAMED
- Device Name
- Syringe Assy 50UL EUDAMEDSyringe Assembly 500UL EUDAMEDWash Syringe Seal EUDAMEDSyringe Seal Dilutor Block, ACL EUDAMED
- Model / Reference
- BK-448947D EUDAMEDBK-467729D EUDAMEDOY-B16554/1D EUDAMEDIL-18102002/1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811403011247 EUDAMED00811403011537 EUDAMED00811403010646 EUDAMED00811403015597 EUDAMED
- Basic UDI-DI
- 081140301BK448947DGJ EUDAMED081140301BK467729DGF EUDAMED081140301OYB16554/1DW2 EUDAMED081140301IL18102002/15G EUDAMED
- EMDN Code
- W05020180 SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES EUDAMEDW05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Syringe by DIAMOND DIAGNOSTICS Inc — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301BK448947DGJ | Class A | Active |
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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 (4)
- EUDAMED 21689cc6-d3b0-41ac-bf01-1bec78a2adf0 61 fields · synced Aug 2, 2026
- EUDAMED 39fd2017-8166-467a-b60f-5ac75ecd5da3 61 fields · synced May 18, 2026
- EUDAMED 8d1e019d-b025-4487-8145-2496f3caa00b 61 fields · synced May 18, 2026
- EUDAMED 6fcf840b-6533-4287-8dda-f5e139c28a5b 61 fields · synced May 19, 2026