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cobas 8000 ISE 900 Module
EUDAMEDClass A (EU MDR)
Ref 05641497001Model cobas 8000 modular analyzer series
Identity
- Trade Name
- cobas 8000 ISE 900 Module EUDAMED
- Device Name
- cobas 8000 ISE 900 Module EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED05641497001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015630928347 EUDAMED
- Basic UDI-DI
- 761333601372AL EUDAMED
- EMDN Code
- W0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200) 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
cobas 8000 ISE 900 Module by Hitachi High-Tech Corporation — 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 | 761333601372AL | Class A | Active |
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Manufacturer
- Manufacturer
- Hitachi High-Tech Corporation
- EUDAMED SRN
- JP-MF-000016991
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (1)
- EUDAMED 0323e777-8ed0-46a9-88fa-340ad3616a57 61 fields · synced Jun 18, 2026