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cobas 8000 ISE 1800 Module
EUDAMEDFDA UDIClass A (EU MDR)
Ref 05964075001Model cobas 8000 modular analyzer series
Identity
- Trade Name
- cobas 8000 ISE 1800 Module EUDAMEDcobas 8000 cobas ISE module FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- cobas 8000 ISE 1800 Module EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED05964075001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 05964075001 FDA UDI
- Primary DI / UDI-DI
- 04015630946341 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601394AW EUDAMED
- 510(k) Number
- K100853 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200) EUDAMED
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
cobas 8000 ISE 1800 Module by Hitachi High-Tech Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 761333601394AW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hitachi High-Tech Corporation
- EUDAMED SRN
- JP-MF-000016991
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (2)
- EUDAMED 55314e3b-384e-47fd-8ec6-725f08424825 61 fields · synced Jul 12, 2026
- FDA UDI 747d338c-06c7-4c9c-acef-467e0a103e7c 35 fields · synced May 30, 2026