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cobas 8100 automated workflow series Language Pack – Portuguese Version 4.5.1.pt
EUDAMEDClass A (EU MDR)
Ref 09722050001Model cobas 8100 automated workflow seriesRef 09505954001Ref 10716312001Ref 10652870001Ref 09857079001
Identity
- Trade Name
- cobas 8100 automated workflow series Language Pack – Portuguese Version 4.5.1.pt EUDAMEDcobas 8100 automated workflow series Language Pack – Portuguese Version 4.4.1.pt EUDAMEDcobas 8100 automated workflow series Language Pack - Portuguese Version 4.11.pt EUDAMEDcobas 8100 automated workflow series Language Pack - Portuguese Version 4.10.pt EUDAMEDcobas 8100 automated workflow series Language Pack - Portuguese Version 4.6.1.pt EUDAMED
- Device Name
- cobas 8100 automated workflow series Language Pack Version 4.5.1 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.4.1. EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.11 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.10 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.6.1 EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED09722050001 EUDAMED09505954001 EUDAMED10716312001 EUDAMED10652870001 EUDAMED09857079001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336216453 EUDAMED07613336203460 EUDAMED07613336243398 EUDAMED07613336241745 EUDAMED07613336222072 EUDAMED
- Basic UDI-DI
- 761333602581B6 EUDAMED761333602197AZ EUDAMED761333603408AW EUDAMED761333603362AX EUDAMED761333602692BG 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 4.5.1.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 | 761333602581B6 | 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 (5)
- EUDAMED 95e89c71-0b25-48e1-80f1-1d25b8e2805b 61 fields · synced Oct 6, 2026
- EUDAMED 64e6d077-d6ed-4196-aae9-c69044079221 61 fields · synced May 18, 2026
- EUDAMED 8b5d847c-f69d-490c-8b02-b1e0704334cc 61 fields · synced May 18, 2026
- EUDAMED 7c83ef72-8b43-4d58-8cda-5f89214a44cb 61 fields · synced May 19, 2026
- EUDAMED 4b64a725-e554-48e7-8a52-b561f96413cf 61 fields · synced May 19, 2026