← Back to catalogue
Magphan®
EUDAMEDClass I (EU MDR)
Ref SMR100Ref TMR008Ref SMR170Ref TMR022Model Magphan® RTRef EMR128Model Magphan® Ref SMR172Ref TMR047
Identity
- Trade Name
- Magphan® EUDAMEDMagphan® RT EUDAMED
- Device Name
- SMR100 EUDAMEDTMR008 EUDAMEDSMR170 EUDAMEDTMR022 EUDAMEDEMR128 EUDAMEDSMR172 EUDAMEDTMR047 EUDAMED
- Model / Reference
- SMR100 EUDAMEDTMR008 EUDAMEDSMR170 EUDAMEDMagphan® RT EUDAMEDTMR022 EUDAMEDMagphan® EUDAMEDEMR128 EUDAMEDSMR172 EUDAMEDTMR047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SMR100HL EUDAMEDD-TMR008JC EUDAMEDD-SMR170J9 EUDAMEDD-TMR022J6 EUDAMEDD-EMR128CL EUDAMEDD-SMR172JD EUDAMEDD-TMR047JN EUDAMED
- Basic UDI-DI
- B-SMR100HL EUDAMEDB-TMR008JC EUDAMEDB-SMR170J9 EUDAMEDB-TMR022J6 EUDAMEDB-EMR128CL EUDAMEDB-SMR172JD EUDAMEDB-TMR047JN 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
Magphan® 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-SMR100HL | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phantom Laboratory
- EUDAMED SRN
- US-MF-000027490
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (7)
- EUDAMED 43ec7d40-7cf7-4f63-90e3-9cc6dffa4bfc 61 fields · synced Jul 31, 2026
- EUDAMED 038785d1-4913-488b-bd61-88b66d3a7613 61 fields · synced May 16, 2026
- EUDAMED d46f9839-8d4a-454e-bc35-e8a5ac81a928 61 fields · synced May 17, 2026
- EUDAMED a538770b-6499-4fd8-b6c5-c5037f328bfd 61 fields · synced May 18, 2026
- EUDAMED 054537c0-fe3f-4c3e-b274-fc022e055910 61 fields · synced May 18, 2026
- EUDAMED 5f22072f-50ad-4256-8c0a-8bc1684d156e 61 fields · synced May 18, 2026
- EUDAMED 4d18ef4e-5da7-4395-9265-83c4a9f9f7c9 61 fields · synced May 18, 2026