MASENA INVEST, BV

FDA Device Registration & Listing · Dordrecht Zuid-Holland, NL · Registration 3012312061

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
3012312061
FEI Number
3012312061
Entity Name
MASENA INVEST, BV
City/State/Country
Dordrecht Zuid-Holland, NL
Establishment Address
Burgemeester de Raadtsingel 71, Dordrecht Zuid-Holland 3311 JG, NL
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Masena Invest, BV (Owner Number: 10052668)
Owner / Operator Contact Address
Burgemeester de Raadtsingel 71, Dordrecht, NL-NOTA 3311 JG, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K153149
PMA Number
N/A

All Registered Proprietary Names

iProven NCT- 336BLUE NCT-336BLACK FK-127-co FK-127-co FK-127-co

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-01-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-01-03
DQA Oximeter Cardiovascular Class 2 870.2700 2018-04-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-09-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-02-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-06
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2018-04-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-03-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-03-27
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2019-08-09
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2019-08-09
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2019-08-09
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2019-08-09
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2019-08-09
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 2016-09-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-06
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2017-09-11
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2017-09-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-06

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

Masena Invest, BV
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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012312061. Last updated year: 2026. Please use registration number 3012312061 when referencing this establishment in official correspondence.
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