Identity
- Device Name
- Diluent for Coagulation Analysis EUDAMED
- Model / Reference
- MCH02507E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802613337 EUDAMED
- Basic UDI-DI
- 69268026MD81Y0000000001HL EUDAMED
- EMDN Code
- W0103020903 BUFFERS (HAEMOSTASIS) 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Diluent for Coagulation Analysis 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 | 69268026MD81Y0000000001HL | 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 71c0a08f-434a-41e8-872b-8a75f952912b 61 fields · synced Jul 8, 2026