← Back to catalogue
Fully Automated Blood Grouping System
EUDAMEDClass A (EU MDR)
Ref BT-70Model BT-70, BT-71
Identity
- Device Name
- Fully Automated Blood Grouping System EUDAMED
- Model / Reference
- BT-70, BT-71 EUDAMEDBT-70 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604021 EUDAMED
- Basic UDI-DI
- 69268026BT70000001N8 EUDAMED
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS 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
Yes
EUDAMED
Fully Automated Blood Grouping System 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 | 69268026BT70000001N8 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 63a3f035-d476-4146-adc1-5233478f13ae 61 fields · synced Jun 18, 2026
- EUDAMED 92dd4947-b009-417a-9837-b43d78c497a8 61 fields · synced Jun 18, 2026