Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006973666

FEI Number

3006973666

Entity Name

Principle & Will Biotech (Pinghu) Co., Ltd.

City/State/Country

Pinghu City Zhejiang, CN

Establishment Address

No. 2000 Xing Ping 2nd Road, Economic Development Zone, Pinghu City Zhejiang 314200, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Principle & Will Biotech (Pinghu) Co., Ltd. (Owner Number: 10025149)

Owner / Operator Contact Address

No. 2000 Xing Ping 2nd Road, Economic Development Zone, Pinghu City, CN-ZJ 314200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tracheobronchial suction catheter kit Bandage, Cast Suction Catheter Mask TRAP, STERILE SPECIMEN Tongue Depressor surgical instrument Syringe GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Needle, hypodermic, single lumen EXAMINATION GOWN Gauze / sponge,nonresorbable for external use wand cover Drape, surgical Shoe Cover L2 and L3 surgical gowns Drape, Surgical surgical drape Cover, cast Coverall Surgical Gown Surgical mask with Fluid Shield Tape and bandage, adhesive Device, Fixation, Tracheal Tube Stockinette Impervious,stocking Dressing,wound, hydrophilic Surgical gown Surgical Cap TOWEL ABSORBENT Sterilization Wrap Mask surgical dress Suction tubing Gown, PP ACCESSORIES, CATHETER Urine collection kit (excludes HIV testing) gown TABLE, CYSTO, NON-ELECTRICAL Mask UNIVERSAL I PACK Face Mask GOWN, SURGICAL STYLET, TRACHEAL TUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2019-08-22
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2015-06-16
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-08-28
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	2020-04-01
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2019-08-02
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2017-09-05
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2011-07-07
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2017-08-28
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2019-08-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-08-22
FME	Gown, Examination	General Hospital	Class 1	880.6265	2015-11-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-08-01
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2010-12-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-03-18
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2015-11-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-10-30
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-17
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2015-11-11
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2015-11-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-21
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-12-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-08-05
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2015-11-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-09-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2019-08-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-07-24
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-11-11
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-02-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2011-06-29
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-18
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-19
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2017-08-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-30
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2017-06-19
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2019-08-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-03-18
EYH	Table, Cysto, Non-Electrical	Gastroenterology, Urology	Class 1	876.4890	2015-12-28
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-18
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2010-03-01
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2009-09-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-10-30
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2019-08-01

Official Correspondent

Phil Chuang

US Agent Details

James St WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Principle & Will Biotech (Pinghu) 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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3011137372	Teleflex Medical LLC	Morrisville, NC, US
1423395	MEDLINE INDUSTRIES, LP - SPT	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006973666. Last updated year: 2026. Please use registration number 3006973666 when referencing this establishment in official correspondence.