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cobas 8000 c 701 Module
EUDAMEDFDA UDIClass A (EU MDR)
Ref 05641489001Model cobas 8000 modular analyzer series
Identity
- Trade Name
- cobas 8000 c 701 Module EUDAMEDFDA UDI
- Generic Name
- Multi-modality clinical specimen analysis system IVD FDA UDI
- Device Name
- cobas 8000 c 701 Module EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED05641489001 EUDAMED5641489001 FDA UDI
Identifiers
- Catalog Number
- 5641489001 FDA UDI
- Primary DI / UDI-DI
- 04015630928255 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601371AJ 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
- Multi-modality clinical specimen analysis system IVD 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 c 701 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 | 761333601371AJ | 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 56ee5a58-09ef-4b9d-85ab-af25c11950e1 61 fields · synced Jul 15, 2026
- FDA UDI f42afeb7-8b59-4c8a-a139-2efc8c1508be 35 fields · synced May 25, 2026