← Back to catalogue
MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT2101-cTnlModel MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)
Identity
- Trade Name
- MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMED
- Device Name
- cTnI Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMEDBT2101-cTnl EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260214396 EUDAMED
- Basic UDI-DI
- B-06933260214396 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06933260214396 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 25c35a64-9a58-436f-9886-34aa9eb65d6c 61 fields · synced Oct 6, 2026