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cobas pro Transport Line
EUDAMEDFDA UDIClass A (EU MDR)
Ref 09205683001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas pro Transport Line EUDAMEDFDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- cobas pro Transport Line EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED09205683001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 09205683001 FDA UDI
- Primary DI / UDI-DI
- 07613336179512 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601778BL EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ion-selective 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
cobas pro Transport Line 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 | 761333601778BL | 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 a2bbd236-b5bc-43a2-9eaf-499328d4a3aa 61 fields · synced Jun 19, 2026
- FDA UDI 975b39ab-2615-4c18-ad71-10ffb8c9d2c1 33 fields · synced May 30, 2026