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Automatic Specific Proteins Analyzer
EUDAMEDClass A (EU MDR)
Ref ECH9202001Model P 100; P 100S
Identity
- Trade Name
- Automatic Specific Proteins Analyzer EUDAMED
- Device Name
- Automatic Specific Proteins Analyzer EUDAMED
- Model / Reference
- P 100; P 100S EUDAMEDECH9202001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168353554 EUDAMED
- Basic UDI-DI
- 69721683510039N EUDAMED
- Direct Marketing DI
- 06972168353554 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Specific Proteins Analyzer by Maccura Medical Instrument 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 | 69721683510039N | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED a8107e63-a3f0-48d5-901e-698564b0f483 61 fields · synced Jun 19, 2026