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Heparin Assay
EUDAMEDClass IVD General (EU MDR)
Ref MCT00303ERef MCT00304ERef MCT00302E
Identity
- Trade Name
- Heparin Assay EUDAMED
- Device Name
- Heparin Assay EUDAMED
- Model / Reference
- MCT00303E EUDAMEDMCT00304E EUDAMEDMCT00302E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604779 EUDAMED06926802604786 EUDAMED06926802604762 EUDAMED
- Basic UDI-DI
- B-06926802604779 EUDAMEDB-06926802604786 EUDAMEDB-06926802604762 EUDAMED
- EMDN Code
- W0103020199 GENERAL COAGULATION TESTS - 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
No
EUDAMED
Microbial Substances
Yes
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
Heparin Assay 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-06926802604779 | 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 (3)
- EUDAMED e08b66e7-576c-489a-95dc-85b73b73de1e 61 fields · synced Jul 23, 2026
- EUDAMED 4a8bb358-0938-40e5-851b-7595d90f48a5 61 fields · synced May 18, 2026
- EUDAMED 3b382660-138a-4655-b0cf-6b8fc7b8670a 61 fields · synced May 19, 2026