Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012309743

FEI Number

3012309743

Entity Name

Yiwu Ori-Power Medtech Co., Ltd.

City/State/Country

YIWU Zhejiang, CN

Establishment Address

No.86 Xiahe Road, Beiyuan Street, Yiwu,, YIWU Zhejiang 322000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Yiwu Ori-Power Medtech Co.,Ltd. (Owner Number: 10051297)

Owner / Operator Contact Address

No.86 Xiahe Road, Beiyuan Street, Yiwu,, Beishe, Lili, Wujiang, YIWU, CN-JS 322000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

First Aid Blanket And Emergency Survival Blanket YIWU ORI-POWER MEDTECH Cold Pad ORI Power OP- First Aid Series Gloves YIWU ORI-POWER MEDTECH YIWU ORI-POWER MEDTECH Non-Adherent Pad/Non-Stick Pad YIWU ORI-POWER MEDTECH BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free YIWU ORI-POWER MEDTECH BANDAGE HYDROPHILIC YIWU ORI-POWER MEDTECH YIWU ORI-POWER MEDTECH Alcohol Prep Pad Safety Pin First Response Medical Supplies YIWU ORI-POWER MEDTECH YIWU ORI-POWER MEDTECH GAUZE Dressing Adhesive Eye Pad Face Mask TRAY, SURGICAL DRESSING YIWU ORI-POWER MEDTECH YIWU ORI-POWER MEDTECH Triangular Bandage YIWU ORI-POWER MEDTECH YIWU ORI-POWER MEDTECH Cotton Swabs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-03-01
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-05-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-03-01
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-05-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-10-25
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2016-03-01
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2018-05-30
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2018-05-30
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-03-01
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-05-30
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2016-03-01
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2018-05-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-03-01
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2016-03-01
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2018-05-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-05-30
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-03-01
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2016-03-01
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-04-18
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2018-05-02
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2018-05-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-03-01
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-03-01
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-07-16
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-03-01
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-03-01
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-05-07
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2018-05-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-03-01
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2026-06-05
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2018-05-07
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-05-30
EFN	Cotton, Roll	Dental	Class 1	872.6050	2016-03-01

Official Correspondent

Oscar Ou

US Agent Details

Solomon Chen Email: regmed.connect@gmail.com Phone: (909) 4387898

Related Public Records

Same Entity

Yiwu Ori-Power Medtech 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
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

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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012309743. Last updated year: 2026. Please use registration number 3012309743 when referencing this establishment in official correspondence.