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2nd IPB for cobas 8100
EUDAMEDClass A (EU MDR)
Ref 08015597001Model cobas 8100 automated workflow series
Identity
- Trade Name
- 2nd IPB for cobas 8100 EUDAMED
- Device Name
- 2nd IPB for cobas 8100 EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED08015597001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336142554 EUDAMED
- Basic UDI-DI
- 761333602169AU EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER 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
Yes
EUDAMED
New Device
No
EUDAMED
2nd IPB for cobas 8100 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 | 761333602169AU | 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 6850fdef-c82a-4d92-b3eb-57eb89b42654 61 fields · synced Aug 3, 2026