FDA.report

ENDOMAGNETICS LTD

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30126444263012644426ENDOMAGNETICS LTD1N2026-01-01330 Cambridge Science Park Milton Road Cambridge Cambridgeshire GB CB4 0WN
30126444263012644426ENDOMAGNETICS LTD1N2020-04-25Endomag, The Jeffreys Building, St Johns innovation Park, Cowley Road Cambridge Cambridgeshire GB CB4 0WS

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3455431087706653P160053MagtraceTM and Sentimag(R) Magnetic Locatization SystemPUV2018-07-24
1925351781482184P160053MagtraceTM and Sentimag(R) Magnetic Locatization SystemPUV2018-07-24
3455431871797829K232865Magseed Pro Magnetic Marker SystemNEU2024-06-28
3455431830109306K222832Sentimag SystemNEU2023-01-21
3455431916766950K173587Magseed Magnetic Marker SysttemNEU2018-02-16
1925351971910537K173587Magseed Magnetic Marker SysttemNEU2018-02-16
3455431243372140K163541Magseed Magnetic Marker SystemPBY2017-01-13
1925351944728634K163541Magseed Magnetic Marker SystemPBY2017-01-13
3455431410986230K153044Sentimag System, Sentimark Magnetic Marker SystermPBY2016-03-02
1925351934675809K153044Sentimag System, Sentimark Magnetic Marker SystermPBY2016-03-02
3455431051975303

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NEU42024-06-28
PBY42017-01-13
PUV22018-07-24

PMA

MagtraceTM and Sentimag(R) Magnetic Locatization System

2022-09-13

ENDOMAGNETICS LTD.330 Cambridge Science Park, Milton Roadcambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Tra...

PMN

GUDID

Sentimag Base Unit - The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

ENDOMAGNETICS LTD

2023-06-20

Sentimag SMP02 Probe Assembly - Device Description: The Sentimag is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

ENDOMAGNETICS LTD

2023-06-20

Sentimag Footswitch Assembly - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

ENDOMAGNETICS LTD

2023-06-20

Sentimag SMC02 Probe Test Phantom - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

ENDOMAGNETICS LTD

2023-06-20

Sentimag SMH02 Probe Holder - Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

ENDOMAGNETICS LTD

2023-06-20