Medical Device
Manufacturer

Licensed medical device manufacturer — Seongnam, Korea

Medical devices, made and registered.

GANA FILL and GANA PATCH, made and registered at our own licensed site in Seongnam, with a registration number a buyer can look up on every product.

01 Main products

Two products, one manufacturer.

Our two main products, both made at the Seongnam site.

GANA FILL family — GANA V and GANA X cartons and freeze-dried PLLA powder vials 01 Dermal filler · PLLA

GANA FILL

Injectable poly-L-lactic acid (PLLA) filler, supplied as a freeze-dried powder and reconstituted before use, on the MFDS register since 2014. The starting point of a filler portfolio that now spans four chemistries, made at our own site.

  • MFDS 제허14-652 Tissue-repair material · 18 Mar 2014
GANA FILL · Product details →
GANA PATCH hydrogel occlusive dressing — cartons and bottles labelled GANA R&D 02 Wound dressing · Hydrogel and foam

GANA PATCH

Hydrogel wound dressing with MFDS domestic approval in Korea and registration in Russia; a foam version is licensed for export. A regulated medical device, not a cosmetic.

  • MFDS 제인20-4997 Topical hydrogel wound dressing · 10 Nov 2020 · Domestic approval
  • Roszdravnadzor РЗН 2024/22431 Topical hydrogel wound dressing · 18 Apr 2024
  • MFDS 제인15-4197 Topical foam wound dressing · 15 Oct 2015
GANA PATCH · Product details →

02 Brands · OEM / ODM partners

Co-development & Manufacturing

From concept and formulation through regulatory development, scale-up and licensed manufacture, on our own site.

Co-development & Manufacturing

03 On the record

A manufacturer, not a distributor.

GANA R&D is a licensed medical device manufacturer in Seongnam, Korea. We formulate, fill and register dermal fillers across four chemistries, manufacture hydrogel and foam wound dressings, and produce under partner brands.

See the registrations →
01
34

Active product registrations with GANA R&D named as manufacturer

02 4

Jurisdictions

03 No. 4490

Manufacturing licence · active since 2014

04 Valid to 2027

GMP conformity · KCL-ABBA-19926

04 Market access

Where we can supply today

Current supply status by territory. The registrations behind each row are on the full list.

Full registration list by jurisdiction →
TerritoryStatusBasis
South Korea Supply available Export — 22 export-designated + 1 domestic (GANA PATCH)
Russia Supply available 8 registrations, named as manufacturer
Brazil Supply available Via local registration holders
United Kingdom Contract manufacture only Brand owned by market-authorisation holder
European Union Not yet available CE expired 27 May 2024; manufacturer registration active
United States Not yet available No FDA device registration

GANA R&D · SEONGNAM

Ask for the registration numbers.

Registration numbers, certificates and dossiers are available to distributors, clinics and brand partners on request.

Contact GANA R&D