FDA Registration
Active
🇮🇳 India
SPM MEDICARE PVT, LTD.
Reg #: 3016707060
·
FEI: 3016707060
·
Expires 2026
Products
21
Proprietary Names
104
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- SPM MEDICARE PVT, LTD.
- Registration Number
- 3016707060
- FEI Number
- 3016707060
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Industrial Building Plot No. 26, Sector 158, Noida, Gautam Buddha Nagar
- City
- NOIDA Uttar Pradesh
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K231724
Owner / Operator
- Firm Name
- SPM MEDICARE PVT, LTD.
- Operator Number
- 10088418
- Address
- B-40, Phase-II, Noida, Gautam Buddha Nagar,
- City
- NOIDA
- State
- Uttar Pradesh
- Postal Code
- 201305
- Country
- IN
- Correspondent
- UMANG MATHUR
US Agent
- Business Name
- STELCORE MANAGEMENT SERVICES LLC
- Contact Name
- Bharat Mandot
- Address
- 8 The Green Suite,, #5766
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 281 8197875
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-05-03 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2023-12-11 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 2023-09-01 |
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2024-01-03 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2023-12-11 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-12-11 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-12-11 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2024-01-03 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2023-12-11 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2023-12-11 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2024-01-03 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2023-12-28 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2023-07-20 |
| Chair, Posture, For Cardiac And Pulmonary Treatment | BYN | Class 1 | Anesthesiology | No | 2024-01-03 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2024-01-03 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-01-03 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2023-12-11 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-03-08 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2023-12-11 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2023-12-11 |
| Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered | KFW | Class 1 | Physical Medicine | No | 2024-01-03 |
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
Elbow Brace compression sleeve Pair
TRUSTMED Ortho Hernia Guard
Hernia Belt
Hernia Guard
TRUSTMED Ortho Knee Support Pair
TRUSTMED Ortho Knee Brace Covered Patella 19"
Knee Brace Covered Patella 19"
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 Arm Sling Pouch
Rigid Plastic cervical collar
TRUSTMED Ortho Hard Collar
Hard Collar
TRUSTMED Ortho Foot Drop Splint
Foot Drop Splint- Right
Foot Drop Splint
Foot Drop Splint- Left
TRUSTMED Ortho Shoulder Immobilizer
Shoulder Immobilizer
Arm Sling Shoulder Immobilizer
Arm Sling Strap
TRUSTMED Ortho Arm Sling Strap
Sternal Splint
TRUSTMED Ortho Sternal Splint
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 Dorso Lumbar Spinal brace
Posture corrector -Magnetic
Posture corrector
Skin Traction Kit with Weight Bag
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 Cervical Collar with Eyelet
TRUSTMED Ortho Lumbo Sacral Belt
TRUSTMED Ortho L S Belt Contour
Lumbo Sacral Belt
L S SUPPORT
Lumbo Sacral Support
L S Belt Contour
Insulin Syringe
TRUSTMED Ortho Cot Splint
Spoon finger splint
Cot Finger splint
TRUSTMED Ortho Spoon Splint
Frog type Finger splint
Base Ball Splint
Baseball finger splint
TRUSTMED Ortho Base Ball Splint
Spoon Splint
Frog Splint
TRUSTMED Ortho Frog Splint
Cot Splint
Clavicle Support
TRUSTMED Ortho Clavicle Support
Tennis Elbow Support
TRUSTMED Ortho Tennis Elbow Support
TRUSTMED Ortho Thumb Spica Splint
TRUSTMED Ortho Wrist Binder
TRUSTMED Ortho Wrist and Forearm Splint (Right)
Thumb Spica Splint
Wrist Thumb Binder
Wrist and Forearm Splint (Right)
TRUSTMED Ortho Wrist and Forearm Splint (Left)
Wrist Cock-Up Splint
Wrist Binder
TRUSTMED Ortho Wrist Thumb Binder
TRUSTMED Ortho Wrist Cock-Up Splint
Wrist and Forearm Splint (Left)
Establishment Types
Manufacture Medical Device