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BCA-1000 Automatic Blood Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref 3017197Model BCA-1000 BCA-3000
Identity
- Trade Name
- BCA-1000 Automatic Blood Coagulation Analyzer EUDAMED
- Device Name
- Automatic Blood Coagulation Analyzer EUDAMED
- Model / Reference
- BCA-1000 BCA-3000 EUDAMED3017197 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576262 EUDAMED
- Basic UDI-DI
- 69257945W0202020102D0KU EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
New Device
No
EUDAMED
BCA-1000 Automatic Blood Coagulation Analyzer by Dirui Industrial Co., Ltd — 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 | 69257945W0202020102D0KU | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 51759e72-03b1-45da-b2de-ea24e61c9b1b 61 fields · synced Jun 18, 2026