← Back to catalogue
Automatic Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref EBL9101004Model H 5000/H 5200
Identity
- Trade Name
- Automatic Coagulation Analyzer EUDAMED
- Device Name
- Automatic Coagulation Analyzer EUDAMED
- Model / Reference
- H 5000/H 5200 EUDAMEDEBL9101004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168351000 EUDAMED
- Basic UDI-DI
- 69721683521029Y EUDAMED
- Direct Marketing DI
- 06972168351000 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 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 | 69721683521029Y | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 9e28bb00-27d2-4024-b586-79c8cfcf61fd 61 fields · synced Oct 7, 2026
- EUDAMED db4aad36-35e8-40d5-a04f-e001d4347baf 61 fields · synced Jul 14, 2026