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Automated Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref Haema N9Model Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp
Identity
- Device Name
- Automated Coagulation Analyzer EUDAMED
- Model / Reference
- Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp EUDAMEDHaema N9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802612576 EUDAMED
- Basic UDI-DI
- 69268026HaemaN900000001X2 EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Automated Coagulation Analyzer by Medcaptain Medical Technology 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 | 69268026HaemaN900000001X2 | Class A | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED c2d040e4-eab2-429b-b20d-d68373384a95 61 fields · synced Jul 22, 2026