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Laser BCR modification kit for UCU
EUDAMEDClass A (EU MDR)
Ref 08433097001Model cobas 8100 automated workflow series
Identity
- Trade Name
- Laser BCR modification kit for UCU EUDAMED
- Device Name
- Laser BCR modification kit EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED08433097001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336169650 EUDAMED
- Basic UDI-DI
- 761333602189B2 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
Laser BCR modification kit for UCU 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 | 761333602189B2 | 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 fe2720de-454c-4ce5-90c1-741f6d213d89 61 fields · synced Jul 28, 2026