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Automatic Blood Coagulation Analyzer Detergent I
EUDAMEDClass A (EU MDR)
Ref 3017199Ref 3019910
Identity
- Trade Name
- Automatic Blood Coagulation Analyzer Detergent I EUDAMED
- Device Name
- Blood Coagulation Reagent EUDAMEDAutomatic Blood Coagulation Analyzer Detergent EUDAMED
- Model / Reference
- 3017199 EUDAMED3019910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576828 EUDAMED06925794577535 EUDAMED
- Basic UDI-DI
- 69257945W0103020999R0SQ EUDAMED
- EMDN Code
- W0103020999 AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Automatic Blood Coagulation Analyzer Detergent I 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 | 69257945W0103020999R0SQ | 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 (2)
- EUDAMED cb17f85b-83b9-4470-86bd-bc18c76a46a5 61 fields · synced Jul 18, 2026
- EUDAMED f9526154-a470-4a05-8234-c9f6a943f4a9 61 fields · synced Jul 18, 2026