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cobas 8100 automated workflow series Language Pack - Spanish Version 4.6.1.es
EUDAMEDClass A (EU MDR)
Ref 09857095001Model cobas 8100 automated workflow seriesRef 10652853001Ref 10716274001Ref 09722076001
Identity
- Trade Name
- cobas 8100 automated workflow series Language Pack - Spanish Version 4.6.1.es EUDAMEDcobas 8100 automated workflow series Language Pack - Spanish Version 4.10.es EUDAMEDcobas 8100 automated workflow series Language Pack - Spanish Version 4.11.es EUDAMEDcobas 8100 automated workflow series Language Pack - Spanish Version 4.5.1.es EUDAMED
- Device Name
- cobas 8100 automated workflow series Language Pack Version 4.6.1 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.10 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.11 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.5.1 EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED09857095001 EUDAMED10652853001 EUDAMED10716274001 EUDAMED09722076001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336222096 EUDAMED07613336241714 EUDAMED07613336243367 EUDAMED07613336216477 EUDAMED
- Basic UDI-DI
- 761333602692BG EUDAMED761333603362AX EUDAMED761333603408AW EUDAMED761333602581B6 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 - Spanish Version 4.6.1.es 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 | 761333602692BG | 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 (4)
- EUDAMED a98569ca-1909-41ec-9e12-1c872344bbc0 61 fields · synced Jul 21, 2026
- EUDAMED 803ecec8-396d-4b01-96c0-ec30a532fcd1 61 fields · synced May 18, 2026
- EUDAMED baed8260-7065-4493-ab07-c22c66c4c62b 61 fields · synced May 19, 2026
- EUDAMED 902ed67a-1936-43ed-8c9d-7fa02c5cdaef 61 fields · synced May 19, 2026