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Automatic Blood Coagulation Analyzer Detergent II
EUDAMEDClass A (EU MDR)
Ref 3017201
Identity
- Trade Name
- Automatic Blood Coagulation Analyzer Detergent II EUDAMED
- Device Name
- Blood Coagulation Reagent EUDAMED
- Model / Reference
- 3017201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576835 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 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 |
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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 377772e4-fc1a-4ea8-be60-8698421c25bf 61 fields · synced Jun 17, 2026