Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009155756

FEI Number

3009155756

Entity Name

Guangzhou Four E's Scientific Co., Ltd.

City/State/Country

GUANGZHOU Guangdong, CN

Establishment Address

Building C, No. 2 Rui Tai Road, Huangpu District, GUANGZHOU Guangdong 510535, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Guangzhou Four E's Scientific Co., Ltd. (Owner Number: 10035903)

Owner / Operator Contact Address

Building C, No. 2, Ruitai Road,, Huangpu District, Guangzhou, CN-GD 510535, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hematocrit Centrifuge Bed Rails Saliva Collection Kit Specimen Container Pasteur Pipette Transfer Pipette Tissue Grinder Magnification Loupes Binocular Loupes Stethoscope OSM100301 Osmometer Freezing Point Osmometer OSM100100 OSM100201 Sterile Centrifuge Tube Slide Warmer Slide Dryer Cover Glass Fluorometer Tube Rotator Tube Roller Tube Rocker Portable Real Time PCR Real Time PCR Paraffin Dispenser Wax Dispenser Dental Mixing Tips Disposable Urinary Drainage Bag Prophylaxis Cup Non-surgical Isolation Gowns Lab Jackets Lab Coats Protective Coveralls Nebulizer 4ERC-MB001, 4ERC-MB002, 4ERC-MB003, 4ERC-MB004, 4ERC-MB005 Portable Mesh Nebulizer, MCN-S600B Biopsy Cassettes Embedding Cassettes Tissue Cassettes Hinged Cassettes Base Mold Clinical Centrifuge CF0201002 MC-6K CF221 MC-7K CF0202003 Mini Centrifuge TM-5000 CF0201001 CF321 Digital Visual Acuity Chart Digital Visual Acuity Checker Pipette Micro Pipette Barrier Envelope PSP Barrier Envelope Instant Cold Pack Instant Perineal Pack Instant Hot Pack Irrigation Tubes Pill Box Pill Organizer Cotton-Tipped Applicators Cotton Applicator Cold Therapy Machine Automatic Pill Dispenser Torque Wrench Torque Ratchet Blackhead Remover Osmolality Standard Osmometer Calibration Standard Hot & Cold Clay Pack Cold Therapy Wrap Reusable Hot or Cold Pack Gel Cold Pack Hot & Cold Gel Pack Nucleic Acid Extraction System MultiEX 096 Nucleic Acid Purification System MultiEX 032 MultiEX 096P MultiEX 016 MultiEX 024L Microscope Slides Gel Warmer Radiation Safety Eyewear Exam Gowns Exam Drapes Exam Shorts Wax Trimmer Block Trimmer Contrast Media Warmer/Locking Incubator Dry Bath Incubator CO2 Incubator Water Bath PCR Tube Pipette Tip Deep Well Plate Centrifuge Tube Cell Culture Plate Cell Culture Flask Petri Dish Sectional Matrix System Matrix Retainers Matrix Bands Low Speed Centrifuge Nasal Oxygen Cannula Tissue Flotation Bath Advanced Tissue Flotation Bath Film Holder Radiography Holder Sensor Holder X-Ray Film Holder Indicator Arm Aiming Ring Patient Lift Electric Chair Lift Electric Floor Lift CGM Adhesive Patches Continuous Glucose Monitor Sensor Adhesive Patches

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKG	Centrifuge, Hematocrit	Hematology	Class 2	864.6400	2023-09-13
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2025-04-10
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-03-19
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2021-03-16
LEC	Grinder, Tissue	Pathology	Class 1	864.3010	2024-08-16
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2024-08-16
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-07-22
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2022-12-08
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2021-04-09
IEG	Table, Slide Warming	Pathology	Class 1	864.3010	2026-05-05
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2024-03-16
JZT	Fluorometer	Immunology	Class 1	866.4520	2026-06-21
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2024-03-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-08-20
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2024-03-16
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2024-11-27
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-04-22
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2024-10-20
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-03
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2021-08-01
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2024-03-16
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2020-08-07
QTO	Digital Visual Acuity Test	Ophthalmic	Class 1	886.1150	2026-04-28
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2021-03-16
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2025-08-29
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-08-13
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2020-08-11
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2021-04-13
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-03-16
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-04-10
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2025-12-07
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-11-17
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2026-04-27
JMZ	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	Clinical Chemistry	Class 1	862.1540	2023-09-25
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-04-01
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-04-16
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2024-03-16
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2025-06-12
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2025-12-07
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-08-08
IDT	Apparatus, Melting Point, Paraffin	Pathology	Class 1	864.3010	2026-05-21
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2024-01-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-01-29
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2024-01-29
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2024-08-15
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2024-01-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-09-14
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2024-03-16
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2024-12-23
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2025-07-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-05-21

Official Correspondent

Nelson Wan

US Agent Details

Rob Sheppard Business: Four E's Industrial Group Inc. Email: rsheppard@4es-usa.com Phone: (609) 4033344

Related Public Records

Same Entity

Guangzhou Four E's Scientific Co., Ltd.

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009155756. Last updated year: 2026. Please use registration number 3009155756 when referencing this establishment in official correspondence.