88000054

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 88000054Model uDR 596i

by Shanghai United Imaging Healthcare Co., Ltd.

Identity

Trade Name: uDR FDA UDI
Generic Name: Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name: Digital Medical X-ray Imaging System FDA UDI
Model / Reference: uDR 596i EUDAMEDFDA UDI
88000054 EUDAMED
Description: Digital Medical X-ray Imaging System FDA UDI

Identifiers

Primary DI / UDI-DI: 06971576833023 EUDAMEDFDA UDI
Basic UDI-DI: B-06971576833023 EUDAMED
510(k) Number: K181413 FDA UDI
K192293 FDA UDI
FDA Product Code: MQB FDA UDI
KPR FDA UDI
EMDN Code: Z11031102 DIRECT DIGITAL TELERADIOGRAPHS EUDAMED
GMDN Term: Stationary basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
Market of Registration: Poland 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

88000054 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — 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-06971576833023	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.
EUDAMED SRN: CN-MF-000008501
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED f3c04115-0ce4-43f2-ac69-2b777438a3b6 61 fields · synced Oct 8, 2026
FDA UDI bae5c084-77ef-4009-9f82-70b4bd48f4d0 35 fields · synced May 30, 2026