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Automatic Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref BH9202019Model H 3600/H 3800
Identity
- Trade Name
- Automatic Coagulation Analyzer EUDAMED
- Device Name
- Automatic Coagulation Analyzer EUDAMED
- Model / Reference
- H 3600/H 3800 EUDAMEDBH9202019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168351642 EUDAMED
- Basic UDI-DI
- 6972168352103A2 EUDAMED
- Direct Marketing DI
- 06972168351642 EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Automatic Coagulation Analyzer by Maccura Medical Instrument 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 | 6972168352103A2 | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 97ba43e6-3c62-4f37-94e3-161025f6186b 61 fields · synced Oct 6, 2026