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DigitalDiagnost 4 High Performance

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 712031

by Philips Medical Systems DMC GmbH

Identity

Trade Name
DigitalDiagnost 4 High Performance EUDAMED
DigitalDiagnost FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
Fixed Rad-System EUDAMED
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support FDA UDI
Model / Reference
712031 EUDAMEDFDA UDI
Description
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support FDA UDI

Identifiers

Catalog Number
712031 FDA UDI
Primary DI / UDI-DI
00884838065321 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM440SS EUDAMED
FDA Product Code
MQB FDA UDI
KPR FDA UDI
LLZ FDA UDI
EMDN Code
Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER 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
892.2050 FDA UDI
Market of Registration
Netherlands 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromagnetic surgical navigation device tracking system

DigitalDiagnost 4 High Performance by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems DMC GmbH
EUDAMED SRN
DE-MF-000005362

Sources (2)

  • EUDAMED 3b8541e4-c517-45ed-831c-883b7afd6de1 61 fields · synced Jun 19, 2026
  • FDA UDI 7b46a2aa-ad12-4c0e-ad34-50cd289c729a 34 fields · synced May 30, 2026