Stephanix

FDA UDI

Class II (US FDA UDI)

by Stephanix

Identity

Trade Name: STEPHANIX FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name: MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography. FDA UDI
Model / Reference: MOVIX DReamy_1040 FDA UDI
Description: MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography. FDA UDI

Identifiers

Primary DI / UDI-DI: 03664049902489 FDA UDI
510(k) Number: K212515 FDA UDI
FDA Product Code: IZL FDA UDI
MQB FDA UDI
GMDN Term: Mobile basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1720 FDA UDI
892.1680 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

Stephanix by Stephanix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K212515 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Stephanix

Sources (1)

FDA UDI 36377b59-83e7-4217-9c84-b3d7e495ee5f 35 fields · synced Jun 8, 2026