Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004488394

FEI Number

3004488394

Entity Name

TIGER MEDICAL GROUP

City/State/Country

SHANGHAI, CN

Establishment Address

JAJE PLAZA, SUITE 703, 1717 NORTH SICHUAN ROAD, SHANGHAI 200080, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ASP Tiger, LLc (Owner Number: 9055664)

Owner / Operator Contact Address

7800 Third Flag Pkwy, --, Austell, GA 30168, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mask, oxygen; various, multiple sterilization pouch/sterilization wrap blood pressure cuff SPONGE FOR EXTERNAL USE (VARIOUS) TIGER NONRESORBABLE GAUZE applicator (sterile) vaginal speculum Specimen Container, Sterile SHOE & SHOE COVER, CONDUCTIVE, MULT Cap various, multiple crutch Razor Tiger Emesis Basins, various EMESIS BAGS Skin staple remover Removable skin staple LARYNGEAL AIRWAY MASK, MULTIPLE DISP. OROPHARYNGEAL AIRWAYS, MULT. Oxygen nasal cannula; various, multiple Tourniquet; various, multiple Isolation gown Mask, oxygen, non-breathing; various, multiple TIGER MANUAL STETHOSCOPE (VARIOUS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2006-11-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2008-12-25
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2011-02-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2012-01-20
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2012-01-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2006-11-15
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2008-12-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2015-02-23
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2017-04-11
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2012-01-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-01-20
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2010-01-08
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2012-01-20
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2014-01-15
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2012-01-20
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2011-01-11
IPR	Crutch	Physical Medicine	Class 1	890.3150	2008-12-25
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-11-15
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2007-11-23
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2010-01-08
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2010-01-08
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2011-02-08
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2006-11-15
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2011-02-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2007-11-29
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2011-02-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2006-11-15
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2014-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Diana Rogers Business: ASP Global Email: diana.rogers@aspglobal.com Phone: (404) 6966999

Related Public Records

Same Entity

ASP Tiger, LLc

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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004488394. Last updated year: 2026. Please use registration number 3004488394 when referencing this establishment in official correspondence.