Identity
- Device Name
- DDP010 EUDAMED
- Model / Reference
- DDP010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DDP0107W EUDAMED
- Basic UDI-DI
- B-DDP0107W EUDAMED
- 510(k) Number
- K082909 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ddp010 by Phantom Laboratory — Class I — FDA_510K, MDD — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082909 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DDP0107W | Class I | Active |
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Manufacturer
- Manufacturer
- Phantom Laboratory
- EUDAMED SRN
- US-MF-000027490
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (2)
- EUDAMED 8366263a-36fd-4a09-8db7-2a318e8cae95 61 fields · synced Jul 13, 2026
- FDA 510(k) K082909 24 fields · synced May 18, 2026