Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010187802

FEI Number

3010187802

Entity Name

SHANDONG JINLAI HUANHAI MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Yantai Shandong, CN

Establishment Address

No.1 Zhonglian Road, Jincheng Town, Laizhou City, Yantai Shandong 261441, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANDONG JINLAI HUANHAI MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10043160)

Owner / Operator Contact Address

No.1 Zhonglian Road, Jincheng Town, Laizhou City, Yantai, CN-SD 261441, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anesthesia breathing bag Woundplast/Band-aid Disposable Gloves MEDICAL RADIATION PROTECTIVE GLOVES Calcium-lime/Carbon dioxide adsorbent/Calcium Lime ABSORBENT, CARBON-DIOXIDE ANESTHESIA BREATHING CIRCUIT KIT Test Lung for anesthesia machine Anaesthetic Mask Carbon dioxide absorber Nasopharyngeal Airway Disposable tourniquet Heat and moisture exchanger Disposable heat and moisture exchanger/filter and components

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2013-01-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-01-15
LZB	Finger Cot	General Hospital	Class 1	880.6250	2026-01-15
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2024-09-27
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2026-01-15
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2026-01-15
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2026-01-15
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2026-01-15
BSF	Absorber, Carbon-Dioxide	Anesthesiology	Class 1	868.5310	2026-01-15
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2026-01-15
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2026-01-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2026-01-15

Official Correspondent

Shifeng Mu

US Agent Details

Paul Li Email: lisa@zxwy-md.com Phone: (312) 9856751

Related Public Records

Same Entity

SHANDONG JINLAI HUANHAI MEDICAL TECHNOLOGY 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2008	Datex Ohmeda, Inc	1	GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.

Similar Registrations

Registration Number	Establishment Name	Location
3014729687	PEDIA	Fairfax, VA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3001313714	UAB INTERSURGICAL	PABRADE Svencionys, LT
3013909820	NINGBO LUKE MEDICAL DEVICES CO., LTD.	Yuyao Zhejiang, CN
3017609572	ZHONGSHAN HONGZE MEDICAL TECHNOLOGY CO., LTD.	Zhongshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010187802. Last updated year: 2026. Please use registration number 3010187802 when referencing this establishment in official correspondence.