Horizon Power Supply Unit (PSU)

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 4806-00

by The Magstim Company Limited

Identity

Trade Name: Horizon Power Supply Unit (PSU) EUDAMED
HORIZON™ Power Supply FDA UDI
Generic Name: Magnetic neural stimulation system, stationary FDA UDI
Device Name: Horizon Power Supply Unit (PSU) EUDAMED
Model / Reference: 4806-00 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 05060229532275 EUDAMEDFDA UDI
Basic UDI-DI: B-05060229532275 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Horizon Power Supply Unit (PSU) 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05060229532275	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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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 a1735fb6-1227-41b5-a2a0-6a090cd73125 61 fields · synced May 29, 2026
FDA UDI 506f0346-cc71-4e93-81a0-c326ddebfb96 34 fields · synced May 26, 2026