← Back to catalogue
cobas pro ISE analytical unit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 08464537001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas pro ISE analytical unit EUDAMEDFDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- cobas pro ISE analytical unit EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED08464537001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08464537001 FDA UDI
- Primary DI / UDI-DI
- 07613336158876 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601581AX 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
- 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
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 pro ISE 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 | 761333601581AX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hitachi High-Tech Corporation
- EUDAMED SRN
- JP-MF-000016991
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (2)
- EUDAMED 935891c0-13e4-4f3f-85a8-8a7269ab9ba8 61 fields · synced Jun 18, 2026
- FDA UDI 7484de60-d0f0-434f-a8c4-3e9adac11562 33 fields · synced May 25, 2026