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cobas pro B-Gate update kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 08763640001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas pro B-Gate update kit EUDAMEDFDA UDI
- Generic Name
- Multi-modality clinical specimen analysis system IVD FDA UDI
- Device Name
- cobas pro B-Gate update kit EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED08763640001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 08763640001 FDA UDI
- Primary DI / UDI-DI
- 07613336164846 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601609AU EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W0201010180,W0201020180 EUDAMED
- GMDN Term
- Multi-modality clinical specimen analysis system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 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
Yes
FDA UDI
cobas pro B-Gate update kit 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 | 761333601609AU | 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 e65f6769-4640-444f-8a95-86c20a172d50 61 fields · synced Jul 16, 2026
- FDA UDI 2d566cec-401d-4f2d-bf81-2e876749fe45 33 fields · synced May 29, 2026