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Horizion MT Remote Coil

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 4990-00

by The Magstim Company Limited

Identity

Trade Name
Horizion MT Remote Coil EUDAMED
HORIZON™ MT Remote Coil FDA UDI
Generic Name
Magnetic neural stimulation system, stationary FDA UDI
Device Name
Horizion MT Remote Coil EUDAMED
Model / Reference
4990-00 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05060229532251 EUDAMEDFDA UDI
Basic UDI-DI
B-05060229532251 EUDAMED
510(k) Number
K171051 FDA UDI
K180907 FDA UDI
K182853 FDA UDI
K183376 FDA UDI
FDA Product Code
OBP FDA UDI
EMDN Code
Z12101105 MAGNETIC STIMULATORS EUDAMED
GMDN Term
Magnetic neural stimulation system, stationary FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.5805 FDA UDI
Market of Registration
Netherlands 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

Yes

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

Horizion MT Remote Coil by The Magstim Company Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Magstim Company Limited
EUDAMED SRN
GB-MF-000003956
Authorised Representative
Technomed Europe NL-AR-000002048

Sources (2)

  • EUDAMED 589f660a-74b2-4300-ba1c-b1b3f2192e61 61 fields · synced Jun 19, 2026
  • FDA UDI a4160f17-bca8-445a-868a-95e6506635ba 34 fields · synced May 30, 2026