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cTnI/CK-MB/Myo Test Kit (Dry Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0AA5-03
Identity
- Device Name
- cTnI/CK-MB/Myo Test Kit (Dry Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 0AA5-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763220117 EUDAMED
- Basic UDI-DI
- B-06971763220117 EUDAMED
- EMDN Code
- W0102160199 SPECIFIC PROTEINS RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
cTnI/CK-MB/Myo Test Kit (Dry Fluorescence Immunoassay) by Lansion 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-06971763220117 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Lansion Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001086
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED faaf8b07-b856-45d4-b859-f77b3329e675 61 fields · synced Sep 17, 2026