FINAPRES MEDICAL SYSTEMS B.V.

FDA Device Registration & Listing · Enschede Overijssel, NL · Registration 3003803088

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003803088
FEI Number
3003803088
Entity Name
FINAPRES MEDICAL SYSTEMS B.V.
City/State/Country
Enschede Overijssel, NL
Establishment Address
Institutenweg 25, Enschede Overijssel 7521 PH, NL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FINAPRES MEDICAL SYSTEMS B.V. (Owner Number: 9051428)
Owner / Operator Contact Address
Institutenweg 25, --, Enschede, NL-OV 7521 PH, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173916
PMA Number
N/A

All Registered Proprietary Names

Finapres NOVA NanoCore

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2018-11-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-11-29
DQA Oximeter Cardiovascular Class 2 870.2700 2018-11-29
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2018-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Marissa Theorin Business: ADINSTRUMENTS, INC. Email: a.perado@adinstruments.com Phone: (719) 3060305

Related Public Records

Same Entity

FINAPRES MEDICAL SYSTEMS B.V.
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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number Establishment Name Location
2025475 VALHALLA SCIENTIFIC, INC. Poway, CA, US
3004987887 USCOM LIMITED SYDNEY New South Wales, AU
3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN
3004782476 Impedimed Limited Lindfield New South Wales, AU
3007305624 GUANGDONG BIOLIGHT MEDITECH CO., LTD Zhuhai Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003803088. Last updated year: 2026. Please use registration number 3003803088 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.