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cobas pro SBL c 503
EUDAMEDFDA UDIClass A (EU MDR)
Ref 09205691001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas pro SBL c 503 EUDAMEDFDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- cobas pro SBL c 503 EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED09205691001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 09205691001 FDA UDI
- Primary DI / UDI-DI
- 07613336179529 EUDAMEDFDA UDI
- Basic UDI-DI
- 761333601779BN 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
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
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 SBL c 503 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 | 761333601779BN | 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 a061b8ea-551b-452c-bca5-c9ae09d01f4a 61 fields · synced Jun 19, 2026
- FDA UDI 34f748ef-a744-44b3-b306-86d0171149c9 33 fields · synced May 29, 2026