Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008773490

FEI Number

3008773490

Entity Name

PAUL E. DANCHELL A/S

City/State/Country

Jyderup Sjalland, DK

Establishment Address

Lyngvej 8, Jyderup Sjalland 4450, DK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Paul E. Danchell A/S (Owner Number: 10042718)

Owner / Operator Contact Address

Lyngvej 8, Jyderup, DK-NOTA 4450, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

°M Warmer System Ultrapro S100 3CP Centrifuge CADScor System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2014-12-23
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2014-12-23
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2014-12-23
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-12-23
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-12-23
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2014-12-23
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2014-12-23
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2015-01-15
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2024-12-11
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2024-12-11
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-29
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2025-01-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2025-01-29
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2025-01-29
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-01-29
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2025-01-29
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-29
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2026-02-24
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2012-12-20
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2012-12-20
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	Cardiovascular	Class 2	870.1420	2024-12-11

Official Correspondent

Claus Jensen

US Agent Details

Travis Garth Business: Global Compliance Plus Email: tgarth@globalcomplianceplus.com Phone: (469) 9394909

Related Public Records

Same Entity

Paul E. Danchell A/S

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
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008773490. Last updated year: 2026. Please use registration number 3008773490 when referencing this establishment in official correspondence.