Medipurpose Pte. Ltd.
Duluth, GA, US
MEDIPURPOSE PTE. LTD. appears in FDA device records in Duluth, GA. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Medipurpose Pte. Ltd. between 2010 and 2022. The busiest year on record is 2010, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 1 |
| 2013 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222224 | SurgiLance® Safety Lancet | FMK | Substantially Equivalent | |
| K130132 | BABYLANCE HEEL INCISION DEVICE | FMK | Substantially Equivalent | |
| K110062 | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG | FRO | Substantially Equivalent | |
| K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | FMK | Substantially Equivalent | |
| K101417 | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 | FMK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614157 | 3008179438 | MEDIPURPOSE PTE. LTD. | 10 Anson Road, SINGAPORE Central Singapore 079903 SG | 2026 | |
| 1066648 | 3003244344 | MEDIPURPOSE, INC. | 2862 Buford Hwy Ste 105, Duluth, GA 30096 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- NABGauze / Sponge,Nonresorbable For External Use
- GDZHandle, Scalpel
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain