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Oncobit PM BRAF V600E2 Control 10rxn
EUDAMEDClass C (EU MDR)
Ref PM-1-01-04-2Model 1.0
by Oncobit AG
Identity
- Trade Name
- Oncobit PM BRAF V600E2 Control 10rxn EUDAMED
- Device Name
- Oncobit PM BRAFV600 EUDAMED
- Model / Reference
- 1.0 EUDAMEDPM-1-01-04-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995954146 EUDAMED
- Basic UDI-DI
- 7649995954PMBRAFIVDRTQ EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Oncobit PM BRAF V600E2 Control 10rxn 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 | 7649995954PMBRAFIVDRTQ | 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 (1)
- EUDAMED 6ddb43ae-cfa1-4ac6-9146-00b3838d8cc9 61 fields · synced Jun 18, 2026