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Fully Automated Blood Grouping System
EUDAMEDClass A (EU MDR)
Ref BT-30Model BT-30, BT-31
Identity
- Trade Name
- Fully Automated Blood Grouping System EUDAMED
- Device Name
- Fully Automated Blood Grouping System EUDAMED
- Model / Reference
- BT-30, BT-31 EUDAMEDBT-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604045 EUDAMED
- Basic UDI-DI
- 69268026BT30000000000018J EUDAMED
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDNetherlands 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
No
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 | 69268026BT30000000000018J | 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 (2)
- EUDAMED eb5d5b05-9ff7-4726-bd12-0841285849c3 61 fields · synced Jun 19, 2026
- EUDAMED 34e96a9d-6570-4375-82e9-1d50640d1d2e 61 fields · synced Jun 19, 2026