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Planmed Clarity
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 20009418
by Planmed Oy
Identity
- Trade Name
- Planmed FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Planmed Clarity EUDAMEDPlanmed Clarity is a mammographic x-ray unit intended for diagnosis of breast cancer FDA UDI
- Model / Reference
- 20009418 EUDAMEDClarity FDA UDI
- Description
- Planmed Clarity is a mammographic x-ray unit intended for diagnosis of breast cancer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035430079 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035430079 EUDAMED
- FDA Product Code
- MUE FDA UDI
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1715 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Planmed Clarity by Planmed Oy — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163328 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06430035430079 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmed Oy
- EUDAMED SRN
- FI-MF-000006837
Sources (3)
- EUDAMED 3904e5fa-889e-4db3-bff9-2451bdef55b1 61 fields · synced Jun 20, 2026
- FDA UDI e211c23c-04bd-4923-af74-9dcaf6b42143 33 fields · synced May 30, 2026
- FDA 510(k) K163328 1 fields · synced May 18, 2026