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Oncobit PM Analyzer
EUDAMEDClass C (EU MDR)
Ref PM-2-00-00-3Model 1.0.0
by Oncobit AG
Identity
- Trade Name
- Oncobit PM Analyzer EUDAMED
- Device Name
- Oncobit PM Analyzer EUDAMED
- Model / Reference
- 1.0.0 EUDAMEDPM-2-00-00-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995954030 EUDAMED07649995954016 EUDAMED
- Basic UDI-DI
- 7649995954PMAnalyzerGE EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C 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
EUDAMEDEUDAMED
Oncobit PM Analyzer by Oncobit AG — Class C — 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 | 7649995954PMAnalyzerGE | Class C | Active |
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Manufacturer
- Manufacturer
- Oncobit AG
- EUDAMED SRN
- CH-MF-000037436
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED aa777a1d-4531-438d-a0fe-a3653aec5acc 61 fields · synced Jul 11, 2026
- EUDAMED a6acf792-2044-4685-9129-586a7e4a9337 61 fields · synced May 19, 2026