Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013510193

FEI Number

3013510193

Entity Name

NINGBO RUNMAI MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Cixi Zhejiang, CN

Establishment Address

NO.777 Binhai 4th Road, HangzhouBay NewZone, Cixi Zhejiang 315300, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Ningbo Runmai Medical Technology Co., Ltd. (Owner Number: 10054250)

Owner / Operator Contact Address

NO.777 Binghai 4th Road, HangzhouBay NewZone, Cixi, CN-ZJ 315300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Runmai Medical Non-rebreathing Mask Runmai Medical Oxygen Mask Reinmed Breathing Circuit NINGBO RUNMAI MEDICAL TUBING, PRESSURE AND ACCESSORIES Soft Tip Nasal Cannula: 6p free material Runmai Medical Oxygen Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2017-12-10
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2017-12-10
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2020-10-13
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2017-12-18
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-02-28
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2017-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Ningbo Runmai Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013510193. Last updated year: 2026. Please use registration number 3013510193 when referencing this establishment in official correspondence.