Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016707060

FEI Number

3016707060

Entity Name

SPM MEDICARE PVT, LTD.

City/State/Country

NOIDA Uttar Pradesh, IN

Establishment Address

Industrial Building Plot No. 26, Sector 158, Noida, Gautam Buddha Nagar, NOIDA Uttar Pradesh 201305, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPM MEDICARE PVT, LTD. (Owner Number: 10088418)

Owner / Operator Contact Address

B-40, Phase-II, Noida, Gautam Buddha Nagar,, NOIDA, IN-UP 201305, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233794

PMA Number

N/A

All Registered Proprietary Names

Easy Oral Oral Dispensing Syringe Easy Oral Oral Dispensing Syringe Ankle Brace TRUSTMED Ortho Ankle Brace TRUSTMED Ortho TRUSTMED Ortho Ankle Support Anklet with Anckle Binder Ankle Support TRUSTMED Ortho Anklet with Anckle Binder EASY BLOOD-COLLECT Arterial Blood Collection Syringe EASY BLOOD-COLLECT EASY BLOOD-COLLECT ABG SYRINGE In-Line Arterial Blood Sampling Set Elbow Support Pair TRUSTMED Ortho Elbow Support Pair TRUSTMED Ortho Elbow Brace compression sleeve Pair TRUSTMED Ortho Hernia Guard TRUSTMED Ortho Hernia Belt Hernia Guard TRUSTMED Ortho Knee Support Pair TRUSTMED Ortho Knee Brace Covered Patella 19" Knee Brace Covered Patella 19" TRUSTMED Ortho TRUSTMED Ortho ROM Knee Brace ROM Knee Brace Knee Immobilizer Knee Support Pair Knee Support Patela Hinged TRUSTMED Ortho Knee Support Patela Hinged Arm Sling Pouch TRUSTMED Ortho TRUSTMED Ortho Arm Sling Pouch Rigid Plastic cervical collar TRUSTMED Ortho Hard Collar Hard Collar TRUSTMED Ortho TRUSTMED Ortho Foot Drop Splint Foot Drop Splint- Right Foot Drop Splint Foot Drop Splint- Left TRUSTMED Ortho TRUSTMED Ortho TRUSTMED Ortho Shoulder Immobilizer Shoulder Immobilizer Arm Sling Shoulder Immobilizer Arm Sling Strap TRUSTMED Ortho Arm Sling Strap Sternal Splint TRUSTMED Ortho Sternal Splint TRUSTMED Ortho Flush Syringe (Prefilled 0.9% normal saline solution) Trustmed Binder Abdominal Abdominal Binder Trustmed Binder Trustmed Abdominal Dorso Lumbar Spinal brace - SHORT, LONG Dorso Lumbar Spinal brace TRUSTMED Ortho Posture corrector -Magnetic TRUSTMED Ortho TRUSTMED Ortho Dorso Lumbar Spinal brace Posture corrector -Magnetic Posture corrector Skin Traction Kit with Weight Bag TRUSTMED Ortho TRUSTMED Ortho Skin Traction Kit with Weight Bag Cervical Collar with Eyelet TRUSTMED Ortho Cervical Collar-Soft Philadelphia Collar Soft form Cervical Collar Philadelphia Cervial Collar Cervical Collar-Soft TRUSTMED Ortho Philadelphia Collar Soft Form Eyelet Cervical Collar TRUSTMED Ortho TRUSTMED Ortho Cervical Collar with Eyelet TRUSTMED Ortho Lumbo Sacral Belt TRUSTMED Ortho L S Belt Contour Lumbo Sacral Belt TRUSTMED Ortho L S SUPPORT Lumbo Sacral Support L S Belt Contour Insulin Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-05-03
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-12-11
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2023-09-01
IRE	Joint, Elbow, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2024-01-03
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2023-12-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-12-11
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-12-11
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2024-01-03
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2023-12-11
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2023-12-11
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2024-01-03
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-12-28
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2023-07-20
BYN	Chair, Posture, For Cardiac And Pulmonary Treatment	Anesthesiology	Class 1	868.5365	2024-01-03
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2024-01-03
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-01-03
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2023-12-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-03-08

Official Correspondent

UMANG MATHUR

US Agent Details

Bharat Mandot Business: STELCORE MANAGEMENT SERVICES LLC Email: bharatmandot@yahoo.com Phone: (281) 8197875

Related Public Records

Same Entity

SPM MEDICARE PVT, 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016707060. Last updated year: 2026. Please use registration number 3016707060 when referencing this establishment in official correspondence.