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Automatic Blood Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref Space1 plusModel XL1000e, XL1000, XL3200c, XL3200t, XL3600c, XL3600t, XL3690t, XL120p, XL120T, XL120L, XL120G, XL120R, XL120c, XL120e, XL120s, XL120i, XL1000c, XL1000i, Space, Space1, Space1 plus, XL3690c, XL1000s
Identity
- Trade Name
- Automatic Blood Coagulation Analyzer EUDAMED
- Device Name
- Automatic Blood Coagulation Analyzer EUDAMED
- Model / Reference
- XL1000e, XL1000, XL3200c, XL3200t, XL3600c, XL3600t, XL3690t, XL120p, XL120T, XL120L, XL120G, XL120R, XL120c, XL120e, XL120s, XL120i, XL1000c, XL1000i, Space, Space1, Space1 plus, XL3690c, XL1000s EUDAMEDSpace1 plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971288641022 EUDAMED
- Basic UDI-DI
- 6971288643E2 EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS 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 Blood Coagulation Analyzer by Beijing ZONCI Technology Development 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 | 6971288643E2 | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing ZONCI Technology Development Co., Ltd
- EUDAMED SRN
- CN-MF-000048322
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED ffca1426-d12b-4a44-b57e-27290bc28678 61 fields · synced Jun 18, 2026