Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016746538

FEI Number

3016746538

Entity Name

AMIS (XIAMEN) CULTURAL CREATIVITY CO., LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

5G1 Unit,Building C1,132 Huachang Road, Huli District, Xiamen Fujian 361000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Amis (xiamen) Cultural Creativity Co., Ltd (Owner Number: 10063867)

Owner / Operator Contact Address

5G1 Unit,Building C1,132 Huachang Road, Huli District, xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic appliance, Correction strap, Correction Belt, Toe Corrector, Breast Implant Stabilizer Band Feeding Tube Backpack Insulin Cooler Travel Case Insulin Bags Chest Belt, Breast Support Bandag Medication Insulated Cooling Bag Infusion Bag Infusion backpack Pediatric IV Backpack IV infusion Backpack Infusion Crossbody Bag IV Bag Medical Bandage CPAP Bandage; Children CPAP Bandage; Medical Tapes Male Urinals Gait belt, Transfer sling, Transfer blanket, Nursing belt Crutch pads, Walker pads, Crutch arm pads, Wheelchair pads, Positioning Pad, Wheelchair bag, Walker bag, Crutch bag, Rollator bag Cane, Crutch and Walker, Rollator, Tips and Pads Urine Drainage Bag, Crutch, Walker, Rollator, Crutch Accessories, Walker Accessories, Rollator Accessories Castor Oil Pack Lift Transfer Chair, Transfer Wheelchair, Lift Transfer WheelChair, Wheelchair, Wheelchair Accessories, Transfer Chair Breast Pump, Wearable Breast Pump Red light therapy, Heating Pad Medical Pediatric Backpack Medical Sling Bag Medical Tactical Backpack Medical Bag CPAP Hose Holder Protective Clothing, Surgical gown, Rehabilitation clothing Isolation Gown Breathing Trainer Infusion backpack Infusion Bag IV Bag IV infusion Backpack Pediatric IV Backpack Infusion Crossbody Bag CPAP Hose and Tubing Surgical Scalpels Surgical Blades, Microtome Blades Diagnostic Tools Medical instruments plate; Surgical Bags Scrub cap, Non-Woven cap, Nurse cap, Doctor cap, Bouffant cap, Disposable cap, Clip cap, Nylon cap, Chemo cap, Cotton cap Scrub Top;Scrubs Pant;Scrub Clothing;Mastectomy Recovery Shirt;Patient clothing;Post Surgery Clothing Medical Scrubs Set;Medical Work Clothes;Medical Uniform Protective Clothing;Surgical Gown;Rehabilitation Clothing; Disposable clothing, Disposable underwear Medical Cap Scrub Uniform, Medical Scrub Uniform Protective Goggles, Safety Goggles, Goggles, Glasses, Sunglasses, Swimming Goggles. Hand Sanitizer;Disinfectants Ear Wax Removal Tool;Breathing Lung expander Device Ear Decompressor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2024-12-23
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2025-12-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-05-26
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-05-26
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2020-03-23
IPR	Crutch	Physical Medicine	Class 1	890.3150	2020-03-23
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2024-05-26
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2024-12-23
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2024-12-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-12-23
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2025-12-04
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-05-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-14
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2024-05-26
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2025-12-04
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2024-05-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-05-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-05-26
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-23
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2020-04-08
LRL	Cushion, Hemorrhoid	Unknown	Class U	N/A	2024-05-26
JZE	Spoon, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-05-26

Official Correspondent

Wenming Qiu

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Amis (xiamen) Cultural Creativity 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016746538. Last updated year: 2026. Please use registration number 3016746538 when referencing this establishment in official correspondence.