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cobas 8100 automated workflow series Language Pack - Portuguese Version 4.8.pt
EUDAMEDClass A (EU MDR)
Ref 10107162001Model cobas 8100 automated workflow series
Identity
- Trade Name
- cobas 8100 automated workflow series Language Pack - Portuguese Version 4.8.pt EUDAMED
- Device Name
- cobas 8100 automated workflow series Language Packs Version 4.8 EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED10107162001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336227725 EUDAMED
- Basic UDI-DI
- 761333602930B9 EUDAMED
- EMDN Code
- W02069082 VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software 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
cobas 8100 automated workflow series Language Pack - Portuguese Version 4.8.pt by Hitachi High-Tech Corporation — Class A — IVDR — listed in EUDAMED
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 | 761333602930B9 | 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 (1)
- EUDAMED 863380f8-05a6-4ae9-aa24-0071c86c4984 61 fields · synced Jun 18, 2026