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sthemA 601
EUDAMEDClass B (EU MDR)
Ref 58878Model sthemA 601Model sthemA 601 (Quark) and Autoloader
Identity
- Trade Name
- sthemA 601 EUDAMEDsthemA 601 (Quark) and Autoloader EUDAMED
- Device Name
- sthemA 601 EUDAMEDsthemA 601 (Quark) and Autoloader EUDAMED
- Model / Reference
- sthemA 601 EUDAMED58878 EUDAMEDsthemA 601 (Quark) and Autoloader EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391521421821 EUDAMED
- Basic UDI-DI
- 53915214QUARKPM EUDAMEDB-05391521421821 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Special Device Type
- Software EUDAMED-1202 EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
sthemA 601 by Tcoag ireland ltd — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 53915214QUARKPM | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 53915214QUARKPM | Class B | Active |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (2)
- EUDAMED 0ace750a-afec-4acb-aea4-51f6a1a03884 61 fields · synced Jul 20, 2026
- EUDAMED 84aeda53-9e2b-4c83-8961-ff1378569f94 61 fields · synced May 18, 2026