← Back to catalogue
Transport Belt 1 (w/o ISE)
EUDAMEDClass A (EU MDR)
Ref 05989990001Model cobas 8000 modular analyzer seriesRef 05642060001
Identity
- Trade Name
- Transport Belt 1 (w/o ISE) EUDAMEDTransport Belt 1 EUDAMED
- Device Name
- Transport Belt 1 (w/o ISE) EUDAMEDTransport Belt 1 EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED05989990001 EUDAMED05642060001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015630943661 EUDAMED04015630943586 EUDAMED
- Basic UDI-DI
- 761333601398B6 EUDAMED761333601374AQ 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 1 (w/o ISE) 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 | 761333601398B6 | Class A | Active |
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 6f0500f1-e327-44f4-b528-0cd19dd0fc52 61 fields · synced Jul 10, 2026
- EUDAMED 6123f73a-30ae-4c7a-958f-fa32959b1484 61 fields · synced May 16, 2026