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Haemostasis Analyzer
EUDAMEDClass A (EU MDR)
Ref Haema T4SModel Haema T4, Haema T4SRef Haema T4
Identity
- Trade Name
- Haemostasis Analyzer EUDAMED
- Device Name
- Haemostasis Analyzer EUDAMED
- Model / Reference
- Haema T4, Haema T4S EUDAMEDHaema T4S EUDAMEDHaema T4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802602836 EUDAMED06926802602829 EUDAMED
- Basic UDI-DI
- 69268026HameaT4001MJ EUDAMED
- EMDN Code
- W0202029001 THROMBELASTOGRAPHS 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
Haemostasis 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 | 69268026HameaT4001MJ | 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 (4)
- EUDAMED 8e797b27-db75-4edd-82d9-4dfc0000854f 61 fields · synced Jul 10, 2026
- EUDAMED f22fb880-6479-4e92-9697-c243de550dd0 61 fields · synced May 18, 2026
- EUDAMED 24a1dce8-7285-441a-990b-f1ce82bccf38 61 fields · synced Jun 19, 2026
- EUDAMED 4411e55d-8aab-4a8e-ae50-b0392b36cfb1 61 fields · synced Jul 10, 2026