SEVENGROUND TRADING B.V.

FDA Device Registration & Listing · Dordrecht Zuid-Holland, NL · Registration 3014015501

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
3014015501
FEI Number
3014015501
Entity Name
SEVENGROUND TRADING B.V.
City/State/Country
Dordrecht Zuid-Holland, NL
Establishment Address
Amstelwijckweg 15, Dordrecht Zuid-Holland NL-3316 BB, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Sevenground Trading B.V. (Owner Number: 10055925)
Owner / Operator Contact Address
Amstelwijckweg 15, Dordrecht, NL-ZH NL-3316 BB, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K053236
PMA Number
N/A

All Registered Proprietary Names

FK-127-co FK-127-Co FK-127-Co

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-03
DQA Oximeter Cardiovascular Class 2 870.2700 2018-04-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-03-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-08-01
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-08-01
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-01
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-02-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-20
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2017-10-18
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2017-10-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-12-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-03-27
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2018-04-17
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

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

Sevenground Trading 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
K964536 Teco Diagnostics ONE-STEP DIPSTICK PREGNANCY TEST 1997-02-11
K904016 Bhc Biotech , Ltd. MAXI TEST 1990-10-15
K870259 Leeco Diagnostics, Inc. VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 1987-03-10
K820822 Hybritech, Inc. TANDEM HCG KIT 1982-04-29
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
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
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014015501. Last updated year: 2026. Please use registration number 3014015501 when referencing this establishment in official correspondence.
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