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cobas e 411 analyzer (rack system)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 04775279001Model cobas e 411 analyzer
Identity
- Trade Name
- cobas e 411 analyzer (rack system) EUDAMEDcobas e 411 Immunoassay Analyzer FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- cobas e 411 analyzer (rack system) EUDAMED
- Model / Reference
- cobas e 411 analyzer EUDAMED04775279001 EUDAMED04775201001 FDA UDI
Identifiers
- Catalog Number
- 04775201001 FDA UDI
- Primary DI / UDI-DI
- 04015630924721 EUDAMEDFDA UDI
- Basic UDI-DI
- 7613336013209Z EUDAMED
- 510(k) Number
- K961481 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Chemiluminescent immunoassay analyser 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
No
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
No
FDA UDI
cobas e 411 analyzer (rack system) 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 | 7613336013209Z | 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 02842b19-f2e1-4d4c-8de8-d6f59ef67968 61 fields · synced Jul 29, 2026
- FDA UDI eb61db62-ba51-4585-b68b-cbef2cb4e4e2 34 fields · synced May 30, 2026