Identity
- Trade Name
- PLANET Onco Dose EUDAMED
- Device Name
- PLANET Onco Dose EUDAMED
- Model / Reference
- PL1100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B501PLANET0302000 EUDAMED+B501PLANET0301010 EUDAMED
- Basic UDI-DI
- ++B501PLANET030200ZP EUDAMEDB-+B501PLANET0301010 EUDAMED
- Direct Marketing DI
- +B501PLANET0302000 EUDAMED
- EMDN Code
- Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMEDZ11020392 INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED-1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PLANET Onco Dose by Dosisoft — Class IIb — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182966 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | ++B501PLANET030200ZP | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++B501PLANET030200ZP | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dosisoft
- EUDAMED SRN
- FR-MF-000014706
Sources (3)
- EUDAMED 320cbab5-9ea0-414c-96cd-613edd4bc4d8 61 fields · synced Jul 12, 2026
- EUDAMED fcd95b25-0e01-4ca3-9f2e-a9a768c148a7 61 fields · synced May 17, 2026
- FDA 510(k) K182966 1 fields · synced May 18, 2026