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Automatic Blood Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref SpaceModel XL1000e, XL1000, XL3200c, XL3200t, XL3600c, XL3600t, XL3690t, XL120p, XL120T, XL120L, XL120G, XL120R, XL120c, XL120e, XL120s, XL120i, XL1000c, XL1000i, Space, Space1, Space1 plus, XL3690c, XL1000sRef XL3690cRef Space1
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 EUDAMEDSpace EUDAMEDXL3690c EUDAMEDSpace1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971288641008 EUDAMED06971288640698 EUDAMED06971288641015 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 (3)
- EUDAMED 7669f50e-6d7c-4eb2-8efa-9757156cd97c 61 fields · synced Aug 4, 2026
- EUDAMED 5c27e667-77b8-4505-a9f9-97710d00a322 61 fields · synced May 18, 2026
- EUDAMED a27ee200-81d8-410b-8a95-297bcbb820b7 61 fields · synced May 18, 2026