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Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: USCA00000700, USCA00000701, USCA00000702, USCA00000703, USCA00000704, U86581045M"
Identity
- Device Name
- Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- "REF: USCA00000700, USCA00000701, USCA00000702, USCA00000703, USCA00000704, U86581045M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-50A9 EUDAMED
- Basic UDI-DI
- B-6-50A9 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method) by URIT Medical Electronic 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-6-50A9 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ae6c937f-a4eb-4d3c-bd02-8f7a8914c388-1 61 fields · synced Oct 7, 2026
- EUDAMED ae6c937f-a4eb-4d3c-bd02-8f7a8914c388-2 61 fields · synced Jun 20, 2026