← Back to catalogue
Automatic Blood Coagulation Analyzer Detergent II
EUDAMEDClass A (EU MDR)
Ref 3014946
Identity
- Trade Name
- Automatic Blood Coagulation Analyzer Detergent II EUDAMED
- Device Name
- Blood Coagulation Reagent EUDAMED
- Model / Reference
- 3014946 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794522894 EUDAMED
- Basic UDI-DI
- 69257945W0103020999R0SQ EUDAMED
- EMDN Code
- W0103020999 AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Slovenia 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 II 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6f134a22-d995-4549-baad-ae8f2cfcbf0b 61 fields · synced Jun 18, 2026