Sun Nuclear MICRO+ MR

FDA UDI

Class I (US FDA UDI)

by Sun Nuclear Corporation

Identity

Trade Name: Sun Nuclear MICRO+ MR FDA UDI
Generic Name: Laser patient positioning system FDA UDI
Model / Reference: MLB+300MR FDA UDI

Identifiers

Catalog Number: 805898 FDA UDI
Primary DI / UDI-DI: B136MLB300MR0 FDA UDI
FDA Product Code: IWE FDA UDI
GMDN Term: Laser patient positioning system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.5780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Laser patient positioning system

Sun Nuclear MICRO+ MR by Sun Nuclear Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser patient positioning system.

DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
Catalyst+ PT — C-RAD POSITIONING AB · Class IIb
DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
Laser Positioning System — Klarity Medical & Equipment（GZ） Co.,Ltd. · Class I
DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
HIT Laser — C-Rad Positioning AB · Class I
APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
APOLLO blue cross-hair — LAP GmbH Laser Applikationen · Class I

Manufacturer's product page: Sun Nuclear Patents

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sun Nuclear Corporation

Sources (1)

FDA UDI e33370d0-d9cc-499a-b40c-b4cd2e14fb7d 33 fields · synced Jun 8, 2026