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cobas c 513 analyzer
EUDAMEDFDA UDIClass A (EU MDR)
Ref 07649142001Model cobas c 513 analyzer
Identity
- Trade Name
- cobas c 513 analyzer EUDAMEDcobas c 513 clinical chemistry analyzer FDA UDI
- Generic Name
- Multi-modality clinical specimen analysis system IVD FDA UDI
- Device Name
- cobas c 513 analyzer EUDAMED
- Model / Reference
- cobas c 513 analyzer EUDAMED07649142001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 07649142001 FDA UDI
- Primary DI / UDI-DI
- 04015630946327 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601501A7 EUDAMED
- 510(k) Number
- K160571 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) 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 c 513 analyzer 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 | 761333601501A7 | 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 4bb19450-9d4b-43e9-87bd-1205851d9f8d 61 fields · synced Jul 8, 2026
- FDA UDI 0cc641de-3d50-4a19-aa0e-7a52aa181b5d 35 fields · synced May 30, 2026