What does Principle & Will Biotech (Pinghu) Co., Ltd. manufacture?

Registered with the FDA for 39 device types.

Is Principle & Will Biotech (Pinghu) Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Principle & Will Biotech (Pinghu) Co., Ltd. → Supplier → Allomedo

Principle & Will Biotech (Pinghu) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cover, Cast, Bandage, Cast and 37 other device types. Its earliest product listing with the FDA dates from 2008.

39device types registered with the FDA

1recall

Registration

FDA registration record for Principle & Will Biotech (Pinghu) Co., Ltd.
Status	Registered
Registration expires	2026
Registration number	3006973666
FEI number	3006973666
Establishment type	Contract manufacturer, Contract steriliser, Manufacturer

Chinese Registration

Chinese company register details for Principle & Will Biotech (Pinghu) Co., Ltd.
Chinese legal name	宏昌生物医疗科技（平湖）有限公司
Source	export sales certificate, Zhejiang medical products administration

Location

Address of Principle & Will Biotech (Pinghu) Co., Ltd.
City	Pinghu
Province	Zhejiang
Address	No. 2000 Xing Ping 2nd Road
Postal code	314200
Country	China

What It Makes

Device types Principle & Will Biotech (Pinghu) Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessories, Catheter	Class 1	Accessories, Catheter	2017	33
Accessory, Surgical Apparel	Class 1	Mask	2020	439
Bandage, Cast	Class 1	Bandage, Cast	2015	81
Bedding, Disposable, Medical	Class 1	Bedding, Disposable, Medical	2015	308
Blade, Saw, General & Plastic Surgery, Surgical	Class 1	Disposable Blade	2023	25
Cap, Surgical	Class 1	Surgical Cap	2015	178
Catheter And Tip, Suction	Class 2	Yankauer	2017	70
Catheters, Suction, Tracheobronchial	Class 1	Suction Catheter	2017	93
Cover, Barrier, Protective	Class 2	wand cover	2010	15
Cover, Cast	Class 1	Cover, cast	2015	31
Cover, Shoe, Operating-Room	Class 1	Shoe Cover	2015	176
Depressor, Tongue, Non-Surgical	Class 1	Tongue Depressor	2017	100
Device, Fixation, Tracheal Tube	Class 1	Device, Fixation, Tracheal Tube	2015	46
Drape, Surgical, Antimicrobial	Class 2	Drape, surgical	2008	39
Drape, Surgical, Exempt	Class 2	Drape, Surgical, surgical drape	2017	107
Dress, Surgical	Class 1	surgical dress	2020	71
Dressing, Wound, Hydrophilic	Class 1	Dressing,wound, hydrophilic	2019	195
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Class N	Mask	2020	182
Fiber, Medical, Absorbent	Class 1	Towel Absorbent	2015	172
Gauze / Sponge,Nonresorbable For External Use	Class 1	Gauze / sponge,nonresorbable for external use	2019	266
Gauze/Sponge, Internal, X-Ray Detectable	Class 1	Gauze/Sponge, Internal, X-RAY Detectable	2019	67
General Surgery Tray	Class 2	Universal I Pack	2010	24
Gown, Examination	Class 1	Examination Gown	2015	109
Gown, Surgical	Class 2	L2 and L3 surgical gowns, Gown, Surgical, gown, Surgical Gown, Gown, PP	2008	68
Mask, Surgical	Class 2	Surgical mask with Fluid Shield, Face Mask	2009	125
Needle, Hypodermic, Single Lumen	Class 2	Needle, hypodermic, single lumen	2019	71
Non-Surgical Gown	Class 1	Coverall	2015	318
Respirator, Surgical	Class 2	Mask	2020	118
Stocking, Medical Support (For General Medical Purposes)	Class 1	Stockinette Impervious,stocking	2022	76
Stylet, Tracheal Tube	Class 1	Stylet, Tracheal Tube	2019	34
Surgical Instruments, G-U, Manual (And Accessories)	Class 1	surgical instrument	2011	5
Syringe, Irrigating (Non Dental)	Class 1	Syringe	2017	110
Table, Cysto, Non-Electrical	Class 1	Table, Cysto, NON-Electrical	2015	4
Tape And Bandage, Adhesive	Class 1	Tape and bandage, adhesive	2019	353
Tracheobronchial Suction Catheter Kit	Class 1	Tracheobronchial suction catheter kit	2019	9
Trap, Sterile Specimen	Class 2	Trap, Sterile Specimen	2019	19
Tubing, Noninvasive	Class 2	Suction tubing	2017	33
Urine Collection Kit (Excludes Hiv Testing)	Class 1	Urine collection kit (excludes HIV testing)	2019	7
Wrap, Sterilization	Class 2	Sterilization Wrap	2011	38

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Principle & Will Biotech (Pinghu) Co., Ltd.
Initiated	FDA class	Root cause	Reason	Quantity
2017-06-01	Class II	Other	The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.	2,160 units

From the Company

Published by the company on its own website, not by the FDA.

Information published by Principle & Will Biotech (Pinghu) Co., Ltd.
Founded	1973
Main products	Medical masks, Surgical gowns, Surgical hats, Shoe covers, Bedding, Dressings
Export markets	International

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Joykey Industrial (Pinghu) Limited	43
Pinghu Sama Medical Packing Co., Ltd.	4
seca Medical Measuring Systems (pinghu) Co., Ltd.	4
Pinghu Kaiyueda Apparel Co., Ltd.	3
Zhejiang Baron Technologies Co., Ltd.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

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