FDA Registration
Active
🇳🇱 Netherlands
CEVA LOGISTICS NETHERLANDS BV (Venray)
Reg #: 3018783526
·
FEI: 3018783526
·
Expires 2026
Products
61
Proprietary Names
204
Establishment Types
1
Classifications
61
Registration Details
- Registration Name
- CEVA LOGISTICS NETHERLANDS BV (Venray)
- Registration Number
- 3018783526
- FEI Number
- 3018783526
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edisonstraat 2-6
- City
- Oostrum Limburgh
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K991725
Owner / Operator
- Firm Name
- CEVA Logistics Netherlands BV
- Operator Number
- 10086416
- Address
- Edisonstraat 10-12
- City
- Oostrum LB
- State
- NL-NOTA
- Postal Code
- 5807 GG
- Country
- NL
US Agent
- Business Name
- Kay E Knox
- Contact Name
- Kay Knox
- Address
- 4097 E Marquette Ave
- City
- Terre Haute
- State
- IN
- ZIP
- 47805
- Country
- US
- [email protected]
- Phone
- 614 4895164
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-11-08 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2022-11-08 |
| Device, Positive Pressure Breathing, Intermittent | NHJ | Class 2 | Anesthesiology | No | 2022-11-08 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2022-11-09 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2022-11-08 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2022-11-08 |
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2022-11-09 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2022-11-09 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2022-11-08 |
| System, Communication, Powered | ILQ | Class 2 | Physical Medicine | No | 2022-11-09 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-11-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-11-08 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2022-11-08 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2022-11-08 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2022-11-08 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-11-09 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2022-11-09 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-11-08 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2022-11-08 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2022-11-08 |
| Ventilator, External Body, Negative Pressure, Adult (Cuirass) | BYT | Class 2 | Anesthesiology | No | 2024-10-23 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2022-11-08 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2022-11-08 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2022-11-08 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2022-11-08 |
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | Class 2 | Anesthesiology | No | 2022-11-08 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-11-08 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2022-11-08 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2022-11-08 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2022-11-09 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2025-12-11 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2022-11-08 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2022-11-09 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-11-09 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2022-11-08 |
| Transducer, Gas Flow | BXP | Class 1 | Anesthesiology | No | 2022-11-09 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2022-11-08 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2025-12-10 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2022-11-08 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2022-11-08 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2022-11-08 |
| Pillow, Cervical (For Mild Sleep Apnea) | MYB | Class 2 | Dental | No | 2022-11-08 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2024-10-21 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2024-10-23 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2022-11-08 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2024-10-21 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2022-11-08 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-11-08 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2022-11-08 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2022-11-08 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-11-08 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2022-11-09 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2022-11-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-09 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-11-09 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2022-11-09 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-11-09 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-11-09 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-11-09 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-11-09 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2022-11-08 |
Proprietary Names
LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL;
Neonatal Flow and CO2 Sensor, Disposable;
Proximal Flow Sensor, Neonatal
Neonatal Flow and CO2 Sensor, Disposable
CapnoTrak Dehumidification Tubing; Dehumidification Tubing - 1 ft.;
Pediatric and Adult CO2 Airway Adapter, Reusable
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL;
Neonatal and Pediatric CO2 Airway Adapter, Reusable; Proximal Flow Sensor, Neonatal
PEDI NASAL/ORAL CO2 CANULA CAPNOFLEX
CapnoTrak CO2 Nasal Cannula ;
Cannula Nasal/Oral CO2 Adult Capnoflex
SAMPLING LINE MALE LUER-LOK ADAPTER DEH
Cannula Nasal CO2 Adult Capnoflex; Cannula Nasal CO2 Ped Capnoflex
LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL;
Delivery Cannula INFANT/NEONATAL NASAL;
INFANT NASAL CO2/O2 CANNULA
CapnoTrak CO2/O2 Nasal Cannula ;
CapnoTrak O2 Delivery Extension Line;
LoFlo CO2 Sampling Cannula ADULT NASAL;
CapnoTrak CO2/O2 Oral Nasal Cannula
LoFlo CO2 Sampling Cannula PEDIATRIC NASAL;
CapnoTrak CO2 Oral Nasal Cannula;
PEDI NASAL/ORAL CO2 CANNULA CAPNOFLEX
INFANT NASAL CO2 CANNULA CAPNOFLEX
LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL
Sample LIne Male Luer Capnoflex
Nasal Cannula; AC611 High Flow Nasal Cannula;
Cannula Nasal/Oral CO2/O2 Adu Capnoflex
LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL;
CapnoTrak CO2 Sampling Extension Line;
CapnoTrak Water Filter Assembly;
Nasal Cannula;
Cannula Nasal CO2/O2 Adult Capnoflex; Cannula Nasal CO2/O2 Ped Capnoflex
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL;
Sidestream Reusable Neb and Masks
Therapy Mask 3100 NC/SP
Disposable 15mm MPV circuit
Disposable 22mm non-heated passive and heated active circuits
Disposable 15 mm non-heated passive and heated active circuits
Lifeline Personal Response System
Communicator, autoalert help button, mobile help button, personal help button, handse
Philips PED INF Airway Adapter
Philips ADU PED A ADPTR W Humid, M2772A
Philips ADU Oral Nasal CO2 Can, M2756A
Philips ADU Nasal CO2 Cannula, M2744A
Philips PED Oral Nas CO2 O2 Can, M2761A
Philips ADU Oral Nas CO2 O2 Can, M2760A
Philips PED INF A ADPTR W HUMID, M2773A
Philips Sample Line Kit, M2776A
CO2 Nasal Cannula - Infant
Philips INF Nasal CO2 O2 Cannula
Philips PED Oral Nasal CO2 Can, M2757A
Philips ADU PED Airway Adapter, M2768A
Philips Sample Line W HUMID Kit, M2777A
Philips PED Nasal CO2 O2 Cannula, M2751A
IntelliVue Patient Monitors
Philips ADU Nasal CO2 O2 Cannula, M2750A
Mask Cushion Adhesive (AF531)
Philips NM3 Respiratory Monitor w/VentAssist
Disposable Angled Mouthpiece
Mouthpiece Straight
Reusable Mouthpiece
Mouthpiece, Angled
Pegaso V
Sleepmapper (RIMR)
HL7 Interface Utility (RIMR)
DreamStation Cellular Modem (RIST)
AOM (RIMR)
Payer Integration Software (RIMR);
PR1 Wired/Wireless Modems (RIST)
Payer Integration Software (RIMR)
Omnilab Conncect (RIMR)
DreamStation Link Module (RIST)
DreamStation Wi-Fi Accessory (RIST
Encore Basic (RIMR)
Airway Adapter - Single Patient Use - Neonatal
CAPNOSTAT 5 Mainstream Sensor, Maquet
Airway Adapter - Single Patient Use - Adult/Pediatric;
Reusable Adult/Pediatric Airway Adapter
ADULT AIRWAY ADAPTER, QTY 1, MAQUET
Innospire Essence
Innospire Elegance
Innospire Go
I-neb TIM/General Purpose
Airway Adapter - Single Patient Use - Adult/Pediatric
Rapid Actigraphy Data Analyzer Service
Actiware
Actiwatch Spectrum Pro/Plus
Actiwatch Spectrum Pro/Plus + Dock
Peak Flow Meter
Asthma Check
Asthma Mentor
Wisp Nasal Mask
Wisp SE Nasal Mask
LiquiCell CPAP Cushions
NIVO or NIVO Pro Nebulizer
NIVO Pro Nebulizer w/EE or SE Elbow
NM3 Respiratory Profile Monitor
System 22 Aerosol Mask
Threshold Pep
CAPNOSTAT 5 Mainstream CO2 sensor
FloTrak Elite Module wI Capnostat 5 C02 Sensor
Drain, Tee (water trap)
Pediatric Combined CO2/Flow Sensor Series 3
Neonatal Flow Sensor Series 3
CO2/Flow Sensor Adult;
Neonatal Combined CO2/Flow Sensor Series 3
CO2/Flow Sensor Pediatric
CO2/Flow Sensor Neonatal
Pediatric / Adult Combined CO2/Flow Sensor Series 3
Pediatric/Adult Flow Sensor Series 3
Performance Tubing;
Oxygen Manifold Kit
Low Range Cabinet Flow Meter
SmartSleep, Deep Sleep Headband
Respironics LoFlo Sidestream CO2 Module
Respironics Alice, LoFlo, C5 Sidestream Module
Respironics LoFlo Sidestream CO2 Module for GE
Carescape CO2 - LoFlo
C5 LoFlo Sidestream Module; LoFlo Module - RoHS - Private Label
Respironics LoFlo Sidestream CO2 Module for Goldway
Capnography Sensor, Reusable
Capnostat 5 Mainstream CO2 Sensor
Capnostat 5 Mainstream CO2 Sensor for Mindray Medical
Capnostat 5 Mainstream CO2 Sensor for Goldway Medical
Headgear
Chin Strap
Flow Sensor
FloTrak CO2 Sensor
Single-Patient Use Adult Airway Adapte
Single-Patient Use Adult Airway Adapter
Reusable NEO Airway Adapter, Philip
IntelliVue Patient Monito
Reusable ADU-PED Airway Adapter, Philips
Mainstream CO2 Sensor
M3014A Capnography Extension
Patient Circuits
Airway, DEHUM TBG, ADU PED Zoll LoFlo 10
Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10
Cannula, CO2, INF, Zoll LoFlo, 10
Cannula, O2 CO2, PED, Zoll LoFlo, 10
Cannula, O2 CO2, INF, 10, Zoll LoFlo
Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10
Cannula, CO2, ADU, Zoll LoFlo, 10
Airway, DEHUM TBG, PED INF Zoll LoFlo10
Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10
Airway, Adult Pediatric, Zoll LoFlo, 10
Cannula, CO2, PED, Zoll LoFlo, 10
Cannula, CO2 Oral, PED, Zoll LoFlo, 10
Airway, Pediatric Infant, Zoll LoFlo, 10
Cannula, O2 CO2, ADU, Zoll LoFlo, 10
Mini Pegaso A-Cough
Mini Pegaso Cough;
Mini Pegaso A-Cough Perc
Health Band
Flex Trach Adaptor 15 cm, 22M/15F-15F
Flex Trach Adaptor 15 cm, 22M/15
Multiple - Invasive
Performance Tubing 6
DreamStation 2 Roll Stand RIST
Trilogy Evo Mounting Bracket - RIMR
Trilogy Evo Roll Stand RIMR
Trilogy Evo Wheelchair Mount RIMR
DreamStation Roll Stand - RIST
Roll Stand, BiPAP A-series RIMR
Roll Stand, OmniLab Advanced + - RIMR
PTrak FFM
Pediatric Nasal/Oral CO2 Cannula Capnoflex
Sampling Line Male Luer-lok Adapter Dehumidification
Cannula Nasal CO2 Adult Capnoflex;
Cannula Oral/Nasal CO2/O2 Adult Capnoflex D
Cannula Nasal CO2/O2 Adult Capnoflex;
Cannula Nasal CO2 Only Pediatric Capnoflex
Adult Nasal/Oral CO2 Cannula Capnoflex
Infant Nasal CO2/O2 Cannula
Airway Adapter Adult/Pediatric Capnoflex
Infant/Neonatal Airway Adapter Kit Capnoflex
Airway Adapter Adult/Pediatric Nafion Capnoflex
Infant Nasal CO2 Cannula Capnoflex
Airway Adapter Pediatric/Infant Nafion Capnoflex
Sample Line Male Luer Capnoflex
Pediatric Nasal CO2/O2 Cannula Capnoflex
Airway, ADU-PED, SLM LoFlo, 10
CannulaNasal/Oral CO2/O2 PED 704-0022-00
Cannula Nasal CO2/O2 INF 704-0015-00;
AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10
Cannula Nasal/Oral CO2 ADU 704-0017-00
Cannula Nasal CO2 Adult 7040010-00;
Sample Line Male Luer 704-0027-00
Cannula Nasal CO2 PED 704-0012-00;
Sample Line Male Luer Nafion 704-0028-00
CannulaNasal/Oral CO2/O2 ADU 704-0020-00;
Airway Adapter Kit PED/INF 704-0024-00
AirwayAdapter PED/INF Nafion 704-0026-00
Cannula Nasal CO2/O2 PED 704-0016-00;
Cannula Nasal CO2/O2 ADU 704-0014-00;
Pegaso A-Cough Perc
Pegaso Cough
Pegaso A-Cough
PTAF 2, 3, Lite
Pro-Flow and Pro-Flow Plus Cannula Sensors
Pressure Transducer Airflow Sensor (PTAF)
BiPAP Vision
Disposable/FEP/Invasive Circuits
Establishment Types
Export Device to the United States But Perform No Other Operation on Device