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Myoglobin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013853Model 2×50 tests/kitRef 3013735Model 1×50 tests/kitRef 3008758Model 1×100 tests/kit
Identity
- Trade Name
- Myoglobin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Myoglobin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/kit EUDAMED3013853 EUDAMED1×50 tests/kit EUDAMED3013735 EUDAMED1×100 tests/kit EUDAMED3008758 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224041 EUDAMED06925794520296 EUDAMED06925794511874 EUDAMED
- Basic UDI-DI
- B-06942202224041 EUDAMEDB-06925794520296 EUDAMEDB-06925794511874 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Myoglobin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06942202224041 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 7cd81936-b5ed-446f-951c-56ce60809603 61 fields · synced Jul 29, 2026
- EUDAMED 0ad2ff92-f790-4c1f-bebc-f47d72f285f2 61 fields · synced May 17, 2026
- EUDAMED 025f6a98-009b-4460-a48e-4ff20e12caeb 61 fields · synced May 18, 2026