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MR4 Super Pulsed Laser

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 600

by Multi Radiance Medical

Identity

Trade Name
MR4 Super Pulsed Laser EUDAMED
MR4 FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Device Name
MR4 Super Pulsed Laser EUDAMED
Model / Reference
600 EUDAMED
MR4 Super Pulsed Laser Console FDA UDI

Identifiers

Catalog Number
600 FDA UDI
Primary DI / UDI-DI
00852556007022 EUDAMEDFDA UDI
Basic UDI-DI
B-00852556007022 EUDAMED
510(k) Number
K080102 FDA UDI
FDA Product Code
ILY FDA UDI
EMDN Code
Z120615 THERAPEUTIC LASERS EUDAMED
GMDN Term
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Market of Registration
Spain 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

MR4 Super Pulsed Laser by Multi Radiance Medical — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Multi Radiance Medical
EUDAMED SRN
US-MF-000032709
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 40988301-0fdf-47ca-b94f-219334efecd4 61 fields · synced Jul 19, 2026
  • FDA UDI e6730df6-5cc6-46e1-a074-b5d52a98ee5f 34 fields · synced May 30, 2026
  • FDA 510(k) K171354 1 fields · synced May 18, 2026