Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010515547

FEI Number

3010515547

Entity Name

PROMISEMED HANGZHOU MEDITECH CO.,LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 1388 Cangxing Street,, Cangqian Community, Yuhang District, Hangzhou Zhejiang 311121, CN

Establishment Type(s)

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

Owner / Operator

Promisemed Hangzhou Meditech Co.,Ltd. (Owner Number: 10045479)

Owner / Operator Contact Address

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou, CN-ZJ 311121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231792

PMA Number

N/A

All Registered Proprietary Names

Verisafe Safety Sterile Needles Enfit oral syringe Catheter tip syringe Verifine Cooler Travel Case Sensifine Pen Tips TonmiCare PLUS Pen Needles Sensifine Pen Needles Verifine Plus Insulin Pen Needles TonmiCare Pen Needles Verifine Insulin Pen Needles Verifine Pen Needles Verifine Plus Pen Needles TonmiCare Pen Tips Sensifine Lancing Device Verifine Lancing Device VeriEndo Single Use Biopsy Forceps Sol-M Lancing Device VeriEndo Single Use Hemoclips Promisemed Safety Huber Needle Dolpbay Insulin Syringe SOL-CARE Safety Shield Blood Collection Tube Holder Medline Huber Needle with Safety Click Advantage JetCan Safety Huber Needles Promisemed Insulin pen needle Verifine Sterile Gauze Pads ReliOn Sterile Gauze Pads SOL-GUARD Auto-Disable Syringe w/Fixed Needle Hartman Medical Group Blood Transfer Device VeriEndo Endoscopic Injection Needles ONE-CARE Safety Insulin Syringes One-Care OPTI Safety Insulin Syringes ONE-CARE OPTI TB Safety Syringes Promisemed X-Safety Pen Needle Advocate Insulin Pen Needles Verifine Safety Retractable Insulin Syringes VeriSafe Safety Sterile Syringes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-07-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-13
NSC	Injector, Pen	General Hospital	Class 2	880.5860	2019-11-13
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-05-06
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-06-27
OJL	Insulin Vial Protector/Holder	Physical Medicine	Class 1	890.5050	2024-09-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-10-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-07-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-07-20
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2016-12-29
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2023-11-02
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-02-22
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2026-01-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-05-27
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2023-06-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-01-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-10-28
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2025-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-03-16
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-02-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-05-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-05-07
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-12-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-09-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-09-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-05-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-04-24
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-09-05
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-01-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-01-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-09-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-09-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-04-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-04-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-11-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-03-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-09-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2022-04-26
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-12-03
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-08-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-08-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-11-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-09-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-04
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-01-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-06-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-06-27
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2023-02-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2023-10-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-10-07

Official Correspondent

Frank Zhang

US Agent Details

Robert Wernsman Business: PROMISEMED USA Email: wernsmanr@promisemedusa.com Phone: (954) 7320415

Related Public Records

Same Entity

Promisemed Hangzhou Meditech 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
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010515547. Last updated year: 2026. Please use registration number 3010515547 when referencing this establishment in official correspondence.