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Data / Medical devices / India / SPM Medicare Pvt, Ltd.

SPM Medicare Pvt, Ltd.: FDA-registered device maker in NOIDA Uttar Pradesh, India, 2 510(k) clearances

SPM Medicare Pvt, Ltd. is registered with the FDA (registration 3016707060) in NOIDA Uttar Pradesh, India. It lists 22 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 6, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch SPM Medicare Pvt, Ltd.
FDA registration number
3016707060
Address
Industrial Building Plot No. 26, Sector 158, Noida, Gautam Buddha Nagar, NOIDA Uttar Pradesh, India, 201305
Owner or operator
SPM MEDICARE PVT, LTD. (10088418)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 20, 2023
Registered through
2026
Brand names listed
Abdominal, Abdominal Binder, Adult Diapers, Adult Pant Type Diaper, Ankle Brace, Ankle Support, Anklet with Anckle Binder, Arm Sling Pouch and more

Devices it lists

DeviceProduct codeClassRoleSource
Arterial Blood Sampling KitCBT1Manufactureraccessdata.fda.gov
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, PoweredKFW1Manufactureraccessdata.fda.gov
Binder, AbdominalFSD1Manufactureraccessdata.fda.gov
Binder, BreastHEF1Manufactureraccessdata.fda.gov
Chair, Posture, For Cardiac And Pulmonary TreatmentBYN1Manufactureraccessdata.fda.gov
Finger CotLZB1Manufactureraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Manufactureraccessdata.fda.gov
Joint, Ankle, External BraceITW1Manufactureraccessdata.fda.gov
Joint, Elbow, External Limb Component, PoweredIRE1Manufactureraccessdata.fda.gov
Joint, Knee, External BraceITQ1Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Manufactureraccessdata.fda.gov
Orthosis, Cervical-Thoracic, RigidIQF1Manufactureraccessdata.fda.gov
Orthosis, Foot DropOHI1Manufactureraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Manufactureraccessdata.fda.gov
Saline, Vascular Access FlushNGT2Manufactureraccessdata.fda.gov
Sling, ArmILI1Manufactureraccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Manufactureraccessdata.fda.gov
Splint, ClavicleIQJ1Manufactureraccessdata.fda.gov
Splint, TractionHSP1Manufactureraccessdata.fda.gov
Support, HerniaEXN1Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 6, 2024K233794Insulin SyringeFMFSubstantially EquivalentSpm Medicare Pvt. , Ltd.accessdata.fda.gov
November 9, 2023K231724Flush Syringe (Prefilled 0.9% normal saline solution)NGTSubstantially EquivalentSpm Medicare Pvt. , Ltd.accessdata.fda.gov

Compare with other makers

Updated March 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.