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cobas e 801 MSB/MSBL
EUDAMEDFDA UDIClass A (EU MDR)
Ref 08459606 001Model cobas 8000 modular analyzer series
Identity
- Trade Name
- cobas e 801 MSB/MSBL EUDAMEDcobas e 801 Immunoassay analyzer FDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- cobas e 801 MSB/MSBL EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED08459606 001 EUDAMED08459606001 FDA UDI
Identifiers
- Catalog Number
- 08459606001 FDA UDI
- Primary DI / UDI-DI
- 07613336158562 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601562AT EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
- GMDN Term
- Specimen processing instrument 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
cobas e 801 MSB/MSBL 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 | 761333601562AT | 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 af0fc6ae-5a46-465a-92cb-46720a3917b5 61 fields · synced Jun 18, 2026
- FDA UDI 2ae4a1a1-e7c5-403f-bf5a-8f308b73f013 34 fields · synced May 30, 2026