← Back to catalogue
Automatic Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref EBL9201022Model F 680
Identity
- Trade Name
- Automatic Hematology Analyzer EUDAMED
- Device Name
- Automatic Hematology Analyzer EUDAMED
- Model / Reference
- F 680 EUDAMEDEBL9201022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168355176 EUDAMED
- Basic UDI-DI
- 6972168352006A3 EUDAMED
- Direct Marketing DI
- 06972168355176 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B 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
Automatic Hematology Analyzer by Maccura Medical Instrument Co., Ltd. — Class B — 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 | 6972168352006A3 | Class B | 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 (1)
- EUDAMED 6171a6f9-a2f8-4274-b9c3-e7e1444adc09 61 fields · synced Jun 11, 2026