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Thromboelastography Control
EUDAMEDClass IVD General (EU MDR)
Ref MCT00103ERef MCT00102ERef MCT00104ERef MCT00101E
Identity
- Trade Name
- Thromboelastography Control EUDAMED
- Device Name
- Thromboelastography Control EUDAMED
- Model / Reference
- MCT00103E EUDAMEDMCT00102E EUDAMEDMCT00104E EUDAMEDMCT00101E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603888 EUDAMED06926802603871 EUDAMED06926802603895 EUDAMED06926802603864 EUDAMED
- Basic UDI-DI
- B-06926802603888 EUDAMEDB-06926802603871 EUDAMEDB-06926802603895 EUDAMEDB-06926802603864 EUDAMED
- EMDN Code
- W0103020799 HAEMOSTASIS CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Thromboelastography Control by Medcaptain Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06926802603888 | Class IVD General | 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 dcc8dfe0-f472-40c7-946c-329e51c4107a 61 fields · synced Jul 21, 2026
- EUDAMED d7130c43-bcf3-45d1-bc0b-faef3c77ef7a 61 fields · synced May 16, 2026
- EUDAMED 61c31294-0c7f-4c13-9134-20ca2f58409c 61 fields · synced May 17, 2026
- EUDAMED d7d180f9-43a1-4ef2-9627-29e83af722f1 61 fields · synced May 17, 2026