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Fully Automated Blood Grouping System
EUDAMEDClass A (EU MDR)
Ref BT-71Model BT-70, BT-71Ref BT-31Model BT-30, BT-31
Identity
- Trade Name
- Fully Automated Blood Grouping System EUDAMED
- Device Name
- Fully Automated Blood Grouping System EUDAMED
- Model / Reference
- BT-70, BT-71 EUDAMEDBT-71 EUDAMEDBT-30, BT-31 EUDAMEDBT-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604038 EUDAMED06926802604052 EUDAMED
- Basic UDI-DI
- 69268026BT70000001N8 EUDAMED69268026BT30000000000018J EUDAMED
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDNorthern Ireland 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
EUDAMEDEUDAMED
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 |
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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 276bea3a-7568-4cea-a6cf-e2b6f781fc5c 61 fields · synced Jul 14, 2026
- EUDAMED 0d39312a-1829-4336-915c-8ac67c87e7e4 61 fields · synced May 17, 2026
- EUDAMED b5294b73-cb65-40c7-b581-06af7a2537f3 61 fields · synced Jul 9, 2026
- EUDAMED 8a59ccbb-c721-4c14-99d7-479a332ca38d 61 fields · synced Jul 14, 2026