Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681377

FEI Number

1000300598

Entity Name

Nicolay GMBH

City/State/Country

NAGOLD Baden-Wurttemberg, DE

Establishment Address

GRAF-ZEPPELIN-STRASSE 21, NAGOLD Baden-Wurttemberg 72202, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NICOLAY GMBH (Owner Number: 9022544)

Owner / Operator Contact Address

GRAF-ZEPPELIN-STRASSE 21, --, NAGOLD, DE-BW 72202, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

989803152081 : 5 lead snap IEC colored leadset M1425A : 5-lead Set Telemetrie Grabber, AAMI MS23924 : 3-lead ECG Monolead MS20475 : 4lead MonoLead L- 3420mm IEC2 M1191BL : Reusable Adult SpO2 Sensor M1971A : 5-Lead-Set Grabber IEC, ICU (limb) M1540C : 3 Lead AAMI Trunk Cable 0.9m M1626A_old : 3-Lead-Set Mini-Clip unshld IEC 0.7m 124790.1 : 3-Lead Trunk Cable M1622A : CBL Unshielded 3 Ld Miniclip AAMI 0.45m E9003SY : Grab. Leadset M3527A : 7- lead set snap AAMI (7+3) E9003WL : 3-Lead-Set III 989803171841 : CBL ECG 5 lead Snaps, AAMI + SpO2 406641-007 : Leadwire Shld Snap M1615A : CBL Shld ECG 3-lead Set Snaps, IEC M1968A_old : CBL 5 Leadset Grabber AAMI, ICU M1669A : CBL 3 Lead ECG Trunk AAMI/IEC 2.7m 989803171961 : ECG 6 lead Grabber, IEC, Telemetry M1603A : CBL 3-Lead-Set grabbers, AAMI M1604A : CBL 5 Lead-Set, Snap, Chest, IEC, ICU M1647A : CBL unshl. 5-lead Mini-Clip AAMI 0.7/1.3m M1533A : CBL 4 Lead Set Grabber IEC, ICU Rhythmia HDx IEC ECG IN Cable (Trunk) M1609A : ECG 3-Lead Set Non Shld Mini-Clip 406642-008 : Leadwire Shld Grab M1673A : CBL 3-Leadset, Snap, AAMI, ICU M1671A_old : CBL 3-Leadset, Grabber, AAMI, ICU 406642-010 : Leadwire Shld Grab M1424A : Telemetry 5-Lead-Set, snap AAMI 989803199081 : MX40 Adapter SpO2-only E9003WK : 3-Lead-Set III 989803152061 : 5 lead set grabber IEC colored 989803171851 : CBL ECG 5 lead Grabber, AAMI + SpO2 E9003SP : Leadwire Shld Snap 989803151991 : 3 lead snap AAMI gray leadset M2590A : TELE CBL 3 Lead Set Snap AAMI M1640A : 3 lead ECG Patient Trunk Cable, AAMI 406641-006 : Leadwire Shld Snap 130212 : 5-Lead Set LIMB (AAMI) 7499853 : ECG 6-LEAD TRUST AHA/US, TELEM 989803158251 : Label Kit 5+5 Trunk AAMI / IEC MS14687 : 5lead MonoLead L- 4100mm IEC2 060-0108 : Cable Assembly, 3-Lead E9003RF : 3 Lead ECG LD 2 Cable M1580A : CBL 3-lead ECG Patient Trunk, AAMI 0012-00-1813-02 : Cable, ECG LEAD SET, 5L, IEC 989803152141 : 6 Lead Set grabber IEC colored M1581A : ECG Single Lead Mini-Clip 0.7M 5734400 : ECG 5-LEAD SPACER F.MM 12 M1602A : CBL 5 Lead Snap Chest AAMI, ICU E9003YC : 5-Lead Combiner 989803133841 : ECG 3-lead-set grabber AAMI 989803133921 : ECG 6-lead-set grabber AAMI IAA-00439 : 5-Lead-Set AAMI 130219 : 3-Lead Set (AAMI) MS16157 : ECG 6-LEAD SINGLE-PIN EURO, 1M MS28558 : ECG CBL MONOLEAD 5, AHA/US, 5.3M MS28559 : ECG CBL MONOLEAD 6, EURO, 5.3M M2599A : TELE 5-Lead Combiner/Shield Set M2268A, 989803106091, EEG Trunk Cable 2.7 meter 403064-016 : Leadwire Unshld Clip MS17185 : MONOLEAD 6, EURO, 4.8M 408029-001 : Leadwire Set Lead III Snap 989803199071 : MX40 Adapter 6L+SpO2 989803199091 ECG 5 lead Grabber, IEC, SPU, Tele (ECG Lead Set) 989803171871 ECG 6 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803199071 ECG 5 lead Grabber, AAMI, SPU, Tele (ECG Lead Set) 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803199101 ECG 5 Lead Grabber IEC + SpO2, SPU, Tele 989803171831 ECG 5 lead Grabber, AAMI, Tele (ECG Lead Set) 989803171961 ECG 6 lead Grabber, IEC, Tele (ECG Lead Set) 989803199081 ECG 5 lead Grabber, AAMI + SpO2, SPU, Tele 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171971 ECG 6 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171931 ECG 5 lead Grabber, IEC, Tele (ECG Lead Set) 989803171861 ECG 6 lead Grabber, AAMI, Tele (ECG Lead Set) 989803171821 ECG 5 lead Snaps, AAMI, Tele (ECG Lead Set) 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) M1968A, 989803125841, 5 Leadset, Grabber, AAMI, ICU M1667A, 989803145051, 6 Lead ECG Trunk, AAMI/IEC 2.7m M1973A, 989803125861, 5 Leadset, Grabber, AAMI, OR M1673A, 989803145111, 3 Leadset, Snap, AAMI, ICU M1665A, 989803145041, 6+4 Lead ECG Trunk AAMI/IEC 2.7m M1644A, 989803144991, 5 Leadset, Snap, AAMI, ICU M1669A, 989803145071, 3 Lead ECG Trunk, AAMI/IEC 2.7m M1624A, 989803144941, Unshielded 3 Ld Miniclip AAMI 0.7m M1671A, 989803145091, 3 Leadset, Grabber, AAMI, ICU M1663A , 989803144791, 10 Lead ECG Trunk AAMI/IEC 2m 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC M1949A, 989803125831, 5+5 ECG Trunk Cable AAMI, IEC 2.7m M1675A, M1624A, M1532A, M1968A, M1644A, M1973A, M1976A, M1602A, M1979A, M1680A, Philips M1602A, 989803144911, 5 Lead Snap Chest AAMI, ICU 989803170171, 989803170181, M1667A, M1668A, M1669A, M1949A, M1663A, M1665A, M1671A ,M1673A 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC M1668A, 989803145061, 5 Lead ECG Trunk, AAMI/IEC 2.7m M1675A, 989803145131, 3 Leadset, Grabber, AAMI, OR M1979A, 989803125901, 5 Leadset, Grabber, Chest, AAMI, OR M1976A, 989803125881, 5 Leadset, Grabber,Chest, AAMI,ICU M1680A, 989803145161, 6 Lead Set Grabber, AAMI, ICU M1532A, 989803144841, 4 Lead Set Grabber AAMI, ICU M1191B and M1191BL 989803202391, Telemetry Adapter Masimo SpO2-only (SpO2 Adapter) 989803143411, Remote Event Marker 989803202381, Telemetry Adapter 5-Lead + Masimo SpO2 (ECG + SpO2 Adapter) 989803204291, Telemetry Adapter 6-Lead + Masimo SpO2 (ECG + SpO2 Adapter) 989803202411, ECG 5L Grabber, AAMI, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) 989803202421, ECG 5L Grabber, IEC, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) M1191T

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2009-03-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-07
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-04-05
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-02-03
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-03-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-12-29
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2026-04-15
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2026-04-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-15
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	Class 2	884.2720	2026-04-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-04-15
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2026-04-15
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-04-15
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2026-04-15
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-04-15
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-04-15
HFN	Transducer, Pressure, Intrauterine	Obstetrics/Gynecology	Class 2	884.2700	2026-04-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2026-04-15
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2026-04-15
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2026-04-15
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2026-04-15
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-04-15
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-04-15
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2026-04-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-04-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

NICOLAY 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
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681377. Last updated year: 2026. Please use registration number 9681377 when referencing this establishment in official correspondence.