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Rapid Hemoglobin/Transferrin Panel Test Card
EUDAMEDClass IVD General (EU MDR)
Ref 1M25C4Ref 1M18C4
Identity
- Trade Name
- Rapid Hemoglobin/Transferrin Panel Test Card EUDAMEDRapid Transferrin Test Card EUDAMED
- Device Name
- Rapid Hemoglobin/Transferrin Panel Test Card EUDAMEDRapid Transferrin Test Card EUDAMED
- Model / Reference
- 1M25C4 EUDAMED1M18C4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963717047 EUDAMED06921963717030 EUDAMED
- Basic UDI-DI
- B-06921963717047 EUDAMEDB-06921963717030 EUDAMED
- EMDN Code
- W0102160299 TUMOUR MARKER RT & POC - OTHER EUDAMEDW0102010307 TRANSFERRIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Rapid Hemoglobin/Transferrin Panel Test Card by Xiamen Boson Biotech 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-06921963717047 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED a7305513-cbcd-40f4-9746-6b410bb4e0da 61 fields · synced Jul 21, 2026
- EUDAMED f51de088-5b51-4cc7-b1f7-91975ad14bcf 61 fields · synced May 19, 2026