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cobas 8100 automated workflow series Language Pack - Romanian Version 4.10.ro
EUDAMEDClass A (EU MDR)
Ref 10652845001Model cobas 8100 automated workflow seriesRef 10286911001Ref 10716339001
Identity
- Trade Name
- cobas 8100 automated workflow series Language Pack - Romanian Version 4.10.ro EUDAMEDcobas 8100 automated workflow series Language Pack - Romanian Version 4.8.ro EUDAMEDcobas 8100 automated workflow series Language Pack - Romanian Version 4.11.ro EUDAMED
- Device Name
- cobas 8100 automated workflow series Language Pack Version 4.10 EUDAMEDcobas 8100 automated workflow series Language Packs Version 4.8 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.11 EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED10652845001 EUDAMED10286911001 EUDAMED10716339001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336241721 EUDAMED07613336231609 EUDAMED07613336243404 EUDAMED
- Basic UDI-DI
- 761333603362AX EUDAMED761333602930B9 EUDAMED761333603408AW 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 - Romanian Version 4.10.ro 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 | 761333603362AX | 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 (3)
- EUDAMED 9e1a8a86-f0e8-46f3-8695-0437f506482c 61 fields · synced Sep 18, 2026
- EUDAMED ad985040-bc17-4742-933d-6be01395e95e 61 fields · synced May 16, 2026
- EUDAMED 052467fe-b074-42f7-b376-e461c2b2508f 61 fields · synced May 19, 2026