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Fully-automated Haemostasis Analyzer
EUDAMEDClass A (EU MDR)
Ref Haema TAModel Fully-automated Haemostasis AnalyzerRef Haema TXModel Haema TX, Haema TA
Identity
- Trade Name
- Fully-automated Haemostasis Analyzer EUDAMED
- Device Name
- Haema TX, Haema TA EUDAMEDFully-automated Haemostasis Analyzer EUDAMED
- Model / Reference
- Fully-automated Haemostasis Analyzer EUDAMEDHaema TA EUDAMEDHaema TX EUDAMEDHaema TX, Haema TA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802602706 EUDAMED06926802602690 EUDAMED
- Basic UDI-DI
- 69268026HameaTX001V7 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
Fully-automated 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 | 69268026HameaTX001V7 | 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 52d49500-01f4-4742-93a3-65b3fe225889 61 fields · synced Jul 23, 2026
- EUDAMED 5a430b86-8c72-4c21-94fc-f1ae2b75956f 61 fields · synced May 19, 2026
- EUDAMED ad6002e4-25aa-4682-a19e-d08dc8473364 61 fields · synced Jun 18, 2026
- EUDAMED 7d133d70-3af9-4a2e-9d1f-1d312e894544 61 fields · synced Jul 23, 2026