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Myo Quantitative Test Kit (Time-Resolved FIA)
EUDAMEDClass IVD General (EU MDR)
Ref FDMYO-402a
Identity
- Trade Name
- Myo Quantitative Test Kit (Time-Resolved FIA) EUDAMED
- Model / Reference
- FDMYO-402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FDMYO-402aHGFY EUDAMED
- Basic UDI-DI
- B-FDMYO-402aHGFY EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Myo Quantitative Test Kit (Time-Resolved FIA) by Healgen Scientific Limited Liability Company — 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-FDMYO-402aHGFY | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 708a3dc6-c83e-4d7e-9b39-4582bf8f9204 61 fields · synced Jul 23, 2026