NEW PROKIN INTERNATIONAL LTD.

FDA Device Registration & Listing · Zhongshan City Guangdong, CN · Registration 3005613467

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
3005613467
FEI Number
3005613467
Entity Name
NEW PROKIN INTERNATIONAL LTD.
City/State/Country
Zhongshan City Guangdong, CN
Establishment Address
No.51,Huashixia St.,Shenchong Village,, Torch Development Zone,, Zhongshan City Guangdong 528437, CN
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
NEW PROKIN INTERNATIONAL LTD. (Owner Number: 9083480)
Owner / Operator Contact Address
No.51,Huashixia St.,ShenChong Village,, Torch Development Zone,, Zhongshan City, CN-GD 528437, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LIFT, PATIENT, NON-AC-POWERED SLING LIFT, PATIENT, NON-AC-POWERED ARC Baby Digital Thermometer SYRINGE, ENT TOOTHBRUSH, MANUAL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2006-02-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-27
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2006-07-13
EFW Toothbrush, Manual Dental Class 1 872.6855 2006-07-13

Official Correspondent

Kevin Tsai

US Agent Details

Tony LEE Email: joyce.tsai@newprokin.com Phone: (469) 5929596

Related Public Records

Same Entity

NEW PROKIN INTERNATIONAL 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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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3008406502 Tollos Sioux Falls, SD, US
3004648937 Winncare Nordic ApS KORSOR Sjalland, DK
3013528441 Green Source Technology (Hebei) Inc. Langfang City Hebei, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005613467. Last updated year: 2026. Please use registration number 3005613467 when referencing this establishment in official correspondence.
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