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cobas c 503 analytical unit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 08463662001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas c 503 analytical unit EUDAMEDFDA UDI
- Generic Name
- Multi-modality clinical specimen analysis system IVD FDA UDI
- Device Name
- cobas c 503 analytical unit EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED08463662001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08463662001 FDA UDI
- Primary DI / UDI-DI
- 07613336158784 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601576B6 EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 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
- 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
No
FDA UDI
cobas c 503 analytical unit 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 | 761333601576B6 | 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 edb42591-dd35-489e-9e50-bbdc5c2c6c6f 61 fields · synced Jul 30, 2026
- FDA UDI f046634e-f234-4bc9-9b30-eb81fd1352de 33 fields · synced May 30, 2026