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Semi-Automatic Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref EBL9101002Model H-04
Identity
- Trade Name
- Semi-Automatic Coagulation Analyzer EUDAMED
- Device Name
- Semi-Automatic Coagulation Analyzer EUDAMED
- Model / Reference
- H-04 EUDAMEDEBL9101002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168355459 EUDAMED
- Basic UDI-DI
- 69721683503WR EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Semi-Automatic Coagulation 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 | 69721683503WR | 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 703f060e-2ac6-4cdc-a38b-84f9d7873b1c 61 fields · synced Oct 6, 2026