Registrations & Market Access
Where we can supply today.
The first question a distributor asks is whether their territory is covered. This page is the answer, followed by every registration behind it.
01 Coverage
| Territory | Status | Basis |
|---|---|---|
| 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 |
02 Distribution partnerships
How we work with distributors
Territorial distribution with phased exclusivity, registration and dossier support for new markets, joint launch and market-development support, and selected joint ventures or co-equity partnerships.
Registration dossiers already exist for the territories above. For a new territory, we support the local registration holder with the documentation the authority requires.
Enquire about a territory03 Manufacturer credentials
Licences and registrations held
- MFDS manufacturing licenceNo. 4490 — active since 2014 · MFDS lookup
- MFDS GMP conformityKCL-ABBA-19926 — valid 4 Mar 2024 to 3 Mar 2027 · MFDS GMP status
- EUDAMED actor registrationKR-MF-000037221 — Manufacturer, active · EUDAMED search
- MHRA manufacturer registrationMAN_ID 32678 — updated 11 Apr 2026 · MHRA PARD
04 Registration library
34 active product registrations
GANA R&D is named as manufacturer on every entry. In Russia and Brazil the registration holder is a local representative; the manufacturer on each certificate is GANA R&D.
South Korea · MFDS · 23
Public lookup →| Registration | Product | Category | Granted | Scope / class | Verify |
|---|---|---|---|---|---|
| 제허25-737 | GANA AH8 | Tissue-repair material | 4 Nov 2025 | Export · Class 4 | Public register→ |
| 제허25-710 | Partner brand | Tissue-repair material | 22 Oct 2025 | Export · Class 4 | Public register→ |
| 제허25-709 | Partner brand | Tissue-repair material | 22 Oct 2025 | Export · Class 4 | Public register→ |
| 제허24-663 | Partner brand | Tissue-repair material | 30 Sept 2024 | Export · Class 4 | Public register→ |
| 제허24-210 | GANA LIDO | Tissue-repair material | 27 Mar 2024 | Export · Class 4 | Public register→ |
| 제허23-426 | Filler X | Tissue-repair material | 17 Mar 2023 | Export · Class 4 | Public register→ |
| 제허23-128 | GANA HA TYPE | Tissue-repair material | 24 Feb 2023 | Export · Class 4 | Public register→ |
| 제허22-751 | Partner brand | Tissue-repair material | 8 Nov 2022 | Export · Class 4 | Public register→ |
| 제허22-423 | GANA HYAL | Tissue-repair material | 1 Jul 2022 | Export · Class 4 | Public register→ |
| 제허22-305 | GANA PN | Tissue-repair material | 16 May 2022 | Export · Class 4 | Public register→ |
| 제허22-304 | GANA PH | Tissue-repair material | 16 May 2022 | Export · Class 4 | Public register→ |
| 제허22-134 | GANA PHV | Tissue-repair material | 25 Feb 2022 | Export · Class 4 | Public register→ |
| 제허22-123 | Art Aqua++ | Tissue-repair material | 23 Feb 2022 | Export · Class 4 | Public register→ |
| 제허22-116 | PNV PLUS (GANA PNV) | Tissue-repair material | 21 Feb 2022 | Export · Class 4 | Public register→ |
| 제허22-55 | CH PLUS | Tissue-repair material | 25 Jan 2022 | Export · Class 4 | Public register→ |
| 제허22-53 | PH PLUS (GANA PH+) | Tissue-repair material | 24 Jan 2022 | Export · Class 4 | Public register→ |
| 제허22-52 | Filler-X PLUS (BFAVGAK PCL FILL) | Tissue-repair material | 24 Jan 2022 | Export · Class 4 | Public register→ |
| 제허21-236 | GANA BOOSTER S (AQUA) | Tissue-repair material | 31 Mar 2021 | Export · Class 4 | Public register→ |
| 제인20-4997 | GANA PATCH | Topical hydrogel wound dressing | 10 Nov 2020 — to 9 Nov 2030 | Domestic · Class 2 | Public register→ |
| 제허15-1662 | GANA HA — Umbrella licence covering ART AQUA and 21 further products | Tissue-repair material | 10 Dec 2015 | Export · Class 4 | Public register→ |
| 제인15-4197 | GANA PATCH foam (GANA DERM) | Topical foam wound dressing | 15 Oct 2015 | Export · Class 2 | Public register→ |
| 제허14-652 | GANA FILL — Umbrella licence covering DIAL LINE and 23 further products | Tissue-repair material | 18 Mar 2014 | Export · Class 4 | Public register→ |
| 제허14-550 | GANALIFT (가나리프트) | Suture and ligature | 5 Mar 2014 | Export · Class 4 | Public register→ |
Russia · Roszdravnadzor · 8
Public lookup →| Registration | Product | Category | Granted | Scope / class | Verify |
|---|---|---|---|---|---|
| РЗН 2021/13973 | GANA X / V | PLLA | 8 Apr 2021 — indefinite | Public register→ | |
| РЗН 2021/14277 | GANA HA (A/B/C) | HA | 7 May 2021 | Public register→ | |
| РЗН 2022/18121 | GANA HA Body | HA | 29 Aug 2022 | Public register→ | |
| РЗН 2024/22431 | GANA PATCH, hydrogel wound dressing | Topical hydrogel wound dressing | 18 Apr 2024 | Public register→ | |
| РЗН 2024/22440 | GANA BOOSTER | HA | 23 Apr 2024 | Public register→ | |
| РЗН 2024/22794 | GANA PH | PLLA + HA | 30 May 2024 | Public register→ | |
| РЗН 2025/26343 | GANA Filler X | PCL + HA | 19 Nov 2025 | Public register→ | |
| РЗН 2025/26344 | GANA CH | calcium + HA | 19 Nov 2025 | Public register→ |
Roszdravnadzor’s registry uses a Russian state certificate. Browsers outside Russia may show a security warning before the record opens.
Brazil · ANVISA · 2
Public lookup →| Registration | Product | Category | Granted | Scope / class | Verify |
|---|---|---|---|---|---|
| 80781300005 | GANA V (210mg/15mL) | PLLA | 2 Aug 2021 — to 2 Aug 2031 | Class IV | Public register→ |
| 80451960236 | Partner brand | PLLA | 14 Dec 2020 — to 14 Dec 2030 | Class IV | Public register→ |
United Kingdom · MHRA · 1
Public lookup →| Registration | Product | Category | Granted | Scope / class | Verify |
|---|---|---|---|---|---|
| DEVICE_ID 73044 | Dermal tissue reconstructive material, PLLA (partner brand) | PLLA | 13 Apr 2021 | Class III | Public register→ |
05 Territory limits
Where supply is limited, and why
- European UnionManufacturer registration is active in EUDAMED. The CE certificate expired on 27 May 2024 and renewal is required before devices can be placed on the EU market.
- United StatesNo FDA device registration. US device distribution cannot be offered.
- United KingdomManufacturer registered with the MHRA. Products in the UK are supplied under a partner's brand, so distribution is contract manufacture only.
Need a certificate, not a summary?
Registration certificates and dossiers are provided to qualified partners on request.