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Automatic Specific Proteins Analyzer Cuvettes
EUDAMEDClass A (EU MDR)
Ref ECH0601803Model 4 Tests
Identity
- Trade Name
- Automatic Specific Proteins Analyzer Cuvettes EUDAMED
- Device Name
- Automatic Specific Proteins Analyzer Cuvettes EUDAMED
- Model / Reference
- 4 Tests EUDAMEDECH0601803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617481744 EUDAMED
- Basic UDI-DI
- 69506174CH0608036V EUDAMED
- Direct Marketing DI
- 06950617481744 EUDAMED
- EMDN Code
- W05030199 SAMPLES ANALYSES, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
New Device
No
EUDAMED
Automatic Specific Proteins Analyzer Cuvettes by Maccura Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69506174CH0608036V | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c1fee6f3-d1e8-4678-9b2a-a3b218e5a9c3 61 fields · synced Oct 6, 2026