Identity
- Trade Name
- Tomophan® EUDAMED
- Device Name
- TSP014 EUDAMEDTSP004 EUDAMED
- Model / Reference
- TSP014 EUDAMEDTSP004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TSP014KT EUDAMEDD-TSP004KQ EUDAMED
- Basic UDI-DI
- B-TSP014KT EUDAMEDB-TSP004KQ EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
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
Tomophan® by Phantom Laboratory — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-TSP014KT | 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 d06ebb36-6b4d-4719-8c59-57472bc1480e 61 fields · synced Jul 28, 2026
- EUDAMED a4b3f28c-0ae7-4724-8c7a-458ecd2e87e8 61 fields · synced May 17, 2026