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CombiDiagnost R90 Rel 1.1

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 709031

by Philips Medical Systems DMC GmbH

Identity

Trade Name
CombiDiagnost R90 Rel 1.1 EUDAMED
CombiDiagnost R90 FDA UDI
Generic Name
Indirect flat panel x-ray detector FDA UDI
Device Name
Remote DRF-System EUDAMED
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes - Adjustable Straps for Patient Support; - Adult headrest; - Ankle Clamps; - Arm Support; - Babix holder vertical stand; - Compression Belt (singles. pull); - Console trolles; - Detector Holder for Patient Bed; - Extra Stitching Ruler; - Hand grips (Pair of); - Handle; - Infusion bottle holder; - Leg Supports (Pair of); - Mattress GXR Systems; - Mobile Detector Holder; - Monitor Ceiling Suspension(Family); - Monitor CS for1 Monitor; - Monitor CS for2 Monitors; - Monitor CS for3 Monitors; - Monitor Trolley Family: - Monitor Trolley for 1 Monitor assembly; - Monitor Trolley for 2 Monitors assembly; - Patient Support for Stitching; - Rotable stool for footrest; - Shoulder supports (Pair of); - Side Bar; - Stretch Grip for VS/VM Stand FDA UDI
Model / Reference
709031 EUDAMEDFDA UDI
Description
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes - Adjustable Straps for Patient Support; - Adult headrest; - Ankle Clamps; - Arm Support; - Babix holder vertical stand; - Compression Belt (singles. pull); - Console trolles; - Detector Holder for Patient Bed; - Extra Stitching Ruler; - Hand grips (Pair of); - Handle; - Infusion bottle holder; - Leg Supports (Pair of); - Mattress GXR Systems; - Mobile Detector Holder; - Monitor Ceiling Suspension(Family); - Monitor CS for1 Monitor; - Monitor CS for2 Monitors; - Monitor CS for3 Monitors; - Monitor Trolley Family: - Monitor Trolley for 1 Monitor assembly; - Monitor Trolley for 2 Monitors assembly; - Patient Support for Stitching; - Rotable stool for footrest; - Shoulder supports (Pair of); - Side Bar; - Stretch Grip for VS/VM Stand FDA UDI

Identifiers

Primary DI / UDI-DI
00884838101456 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM439T9 EUDAMED
FDA Product Code
JAA FDA UDI
EMDN Code
Z11039009 FLUOROSCOPY DEVICES EUDAMED
GMDN Term
Indirect flat panel x-ray detector FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1650 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

CombiDiagnost R90 Rel 1.1 by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
DE-MF-000005362

Sources (2)

  • EUDAMED 999f5648-9f48-4d5d-aa22-a450052dc12e 61 fields · synced Oct 6, 2026
  • FDA UDI 757c31ed-c490-4c11-9016-5c0893b058c8 34 fields · synced May 30, 2026