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c8100 Sysmex Tray OBS mod kit
EUDAMEDClass A (EU MDR)
Ref 08137633001Model cobas 8100 automated workflow series
Identity
- Trade Name
- c8100 Sysmex Tray OBS mod kit EUDAMED
- Device Name
- c8100 HHT 1 tray IPB/OBS mod kit EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED08137633001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336146927 EUDAMED
- Basic UDI-DI
- 761333602187AW EUDAMED
- EMDN Code
- W02069080 VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES 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
c8100 Sysmex Tray OBS mod kit 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 | 761333602187AW | 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 1db06d84-7221-4e12-b6d7-81a261c48841 61 fields · synced Jul 24, 2026