FDA Registration
Active
🇮🇳 India
HEALTHIUM MEDTECH LIMITED
Reg #: 3020983460
·
FEI: 3020983460
·
Expires 2026
Products
8
Proprietary Names
68
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- HEALTHIUM MEDTECH LIMITED
- Registration Number
- 3020983460
- FEI Number
- 3020983460
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PLOT NO.1605, Portia Road, Sri City, Tirupati District
- City
- SRI CITY Andhra Pradesh
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K081002
Owner / Operator
- Firm Name
- HEALTHIUM MEDTECH LIMITED
- Operator Number
- 9064005
- Address
- 472/D, 13TH CROSS, 4TH PHASE, PEENYA INDUSTRIAL AREA
- City
- BANGALORE
- State
- Karnataka
- Postal Code
- 560058
- Country
- IN
- Correspondent
- PANKAJ - DAWAR
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2008-12-15 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | PTX | Class 2 | General, Plastic Surgery | No | 2021-10-09 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2007-11-30 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2008-12-15 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2007-12-01 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2007-12-01 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2007-12-01 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2006-02-22 |
Proprietary Names
Premisut PGCL
MONOPRONE
MONOGLYDE
LINX MONO
Flysorb Mono
Poliglecaprone 25
Monofilament Poliglecaprone 25
U-Monoglyde
TRUGLYDE
VIPRONE
LINX PGA
Flysorb
Braided and Coated Polyglycolic acid
U-Glyde
Premisut PGA
Polyglycolic Acid
TRUSTEEL
U-Steel
Monofilament 316 LVM Stainless steel
Premisut Nylon
TRULON
LINX NYLON
ObereLON
Monomyd
Nylon
Monofilament Polyamide (Nylon)
U-Lon
LINX PDO
ObereDEX
PD Synth
Monofilament Polydioxanone
Polydioxanone
Premisut PDO
U-PD Synth
TRUBOND
X-BOND
LINX BOND
Polytek
Braided and Coated Polyester
Premisut Polyester
Polyester
U-Bond
TRUSYNTH
PREMISUT PGLA-910
LINX GLACTIN 910
Braided and Coated Polyglactin 910
Polyglactin 910
U-Synth
U-Lene
TRULENE
CARDIOPILENE
LINX PROLINE
Monofilament Polypropylene
Polypropylene
Premisut Polypropylene
U-Silk
TRUSILK
LINX SILK
ObereSILK
Silk
Black Braided Silk
Premisut Silk
TRULENE MESH
Premisut Polypropylene Mesh
ObereMESH
LINX MESH
LINX LAPROMESH
Sterile Non-Absorbable Surgical Polypropylene Mesh
Establishment Types
Manufacture Medical Device