Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012272052

FEI Number

3012272052

Entity Name

ONDAL MEDICAL SYSTEMS GMBH

City/State/Country

Huenfeld Hesse, DE

Establishment Address

Wellastr. 6, Huenfeld Hesse 36088, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Ondal Medical Systems GmbH (Owner Number: 10052435)

Owner / Operator Contact Address

Wellastr. 6, Huenfeld, DE-HE 36088, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INFUSION CROSS STRAIGHT INFUSION RACK INFUSION CROSS BEND NuCart VALiA Light Pro (Third Party Light) Med. Supply Unit: Service Head M6(-200; -400; -600; -800; -1000; -Lifter; -Lifter-S); MediSpace; SpacePoint; X-Ray Shield & Monitor Carrier System: VALiA XRAY MRI Monitor Carrier: Vista,(VALiA+, 1-fold; MRI; VALiA+, 2-fold, MRI) Heavy Duty Arms: VALiA X,(EA1; EA2; Boom; EA1/MD; MD60; MD90; MD110; CT110-S; CT110; DT; V; DT; H) Heavy Duty Pendant: MediHoist,(Friction; Power Rail) Monitor Carrier System: VALiA Display; Suspension System Arms: VALiA,(S; S1; S1+; S2; S2+; S3; C1; C2; C1S1; C1S1+; C1S2; C2S1; C2S1+; C2S2; S/C; Triple Plate) MRI Suspension System: VALiA,(C1, MRI; C2, MRI; C, EA2, MRI; S/C,CT110,MRI) Monitor Carrier: CEMOR,( 1; 2; 3; 4; 6; 8; LS; C4; C6; C8; C LS; X 2; X LS) VarioView, (1-fold; 2-fold; 26; 32) Mon. Carrier Accessories: Vista,(handle,steel; handle adapter; handle steriliz.; handle dispos.; VESA 200 adapter; Box) Heavy Duty Arms: MediBoom,(Single; Dual; Friction; Air; AirPlus; Inverted; XL; XXL); MediLift (150; 210; 250; 180; XL) MRI Spring Arms: VALiA,(MD23+; MRI; MD26+; MRI) Monitor Carrier: Vista,(VALiA; VALiA+; OSP) Med. Supply Unit: Ceiling Unit M20 (w/MediBoom-H; w/MediLift-H; w/VALiA X-H; w/MediBoom-V; w/MediLift-V; w/VALiA X-V) Suspension Spring Arms: VALiA,(L; MD; XRS; LCH) Suspension System Arms: ACROBAT 3000; ONDASPACE; SPACEPORT; Central Axis; Hybrid Central Axis; Suspension System Arms: ACROBAT 2000; ACROBAT SWING; ACROBAT 77;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2016-07-28
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2024-10-25
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2025-01-17
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2016-07-28

Official Correspondent

Klaus Steger

US Agent Details

Christopher Walters Business: Ondal Medical Systems of America Email: walters.chris@ondal.com Phone: (804) 5321444

Related Public Records

Same Entity

Ondal Medical Systems GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012272052. Last updated year: 2026. Please use registration number 3012272052 when referencing this establishment in official correspondence.