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Transport Belt 3
EUDAMEDClass A (EU MDR)
Ref 05642094001Model cobas 8000 modular analyzer seriesRef 05990017001
Identity
- Trade Name
- Transport Belt 3 EUDAMEDTransport Belt 3 (w/o ISE) EUDAMED
- Device Name
- Transport Belt 3 EUDAMEDTransport Belt 3 (w/o ISE) EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED05642094001 EUDAMED05990017001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015630943609 EUDAMED04015630943685 EUDAMED
- Basic UDI-DI
- 761333601376AU EUDAMED7613336014009Y EUDAMED
- EMDN Code
- W02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Transport Belt 3 by Hitachi High-Tech Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 761333601376AU | Class A | Active |
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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 7f2a9a2a-c8c7-4931-962c-ae6decae9835 61 fields · synced Jul 14, 2026
- EUDAMED a219ebe0-e8ea-4f9a-bfbc-76aa207b1301 61 fields · synced May 17, 2026