Identity
- Trade Name
- B30 HEMATOLOGY CONTROLS EUDAMED
- Device Name
- B30 HEMATOLOGY CONTROLS EUDAMED
- Model / Reference
- 0031-30-60727 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415992040 EUDAMED
- Basic UDI-DI
- B-06936415992040 EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
B30 Hematology Controls by Shenzhen Mindray Bio-Medical Electronics 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-06936415992040 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9d6db08e-52e8-4f80-9e3a-00bad86cde96 61 fields · synced Jun 19, 2026