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Flore
EUDAMEDClass III (EU MDR)
Ref C2StModel STRONGRef LL2MModel CL-MaxRef LL2SModel CL-SRef LL2ASModel CL-Aqua-sRef LL2UModel CL-UltraRef C2NModel NRef C2UModel ULTRARef C2MModel MAXRef LL2AModel CL-AquaRef LL2M2Model CL-Max1400Ref LL2NModel CL-NRef C2M2Model MAX 1400Ref C2AModel AQUA
Identity
- Trade Name
- FLORE EUDAMEDFLORE Lidocaine EUDAMED
- Device Name
- Cross-linked Hyaluronate Acid Dermal Filler EUDAMEDCross-linked Hyaluronate Acid Dermal Filler with Lidocaine EUDAMED
- Model / Reference
- STRONG EUDAMEDC2St EUDAMEDCL-Max EUDAMEDLL2M EUDAMEDCL-S EUDAMEDLL2S EUDAMEDCL-Aqua-s EUDAMEDLL2AS EUDAMEDCL-Ultra EUDAMEDLL2U EUDAMEDN EUDAMEDC2N EUDAMEDULTRA EUDAMEDC2U EUDAMEDMAX EUDAMEDC2M EUDAMEDCL-Aqua EUDAMEDLL2A EUDAMEDCL-Max1400 EUDAMEDLL2M2 EUDAMEDCL-N EUDAMEDLL2N EUDAMEDMAX 1400 EUDAMEDC2M2 EUDAMEDAQUA EUDAMEDC2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369092594 EUDAMED08809369092952 EUDAMED08809369092921 EUDAMED08809369092938 EUDAMED08809369092969 EUDAMED08809369092532 EUDAMED08809369092570 EUDAMED08809369092563 EUDAMED08809369092976 EUDAMED08809369092990 EUDAMED08809369092945 EUDAMED08809369092600 EUDAMED08809369092587 EUDAMED
- Basic UDI-DI
- B-08809369092594 EUDAMEDB-08809369092952 EUDAMEDB-08809369092921 EUDAMEDB-08809369092938 EUDAMEDB-08809369092969 EUDAMEDB-08809369092532 EUDAMEDB-08809369092570 EUDAMEDB-08809369092563 EUDAMEDB-08809369092976 EUDAMEDB-08809369092990 EUDAMEDB-08809369092945 EUDAMEDB-08809369092600 EUDAMEDB-08809369092587 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flore by BNC KOREA, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809369092594 | Class III | Active |
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Manufacturer
- Manufacturer
- BNC KOREA, Inc.
- EUDAMED SRN
- KR-MF-000008321
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (13)
- EUDAMED b5841a22-6d40-4acf-ae69-679044144229 61 fields · synced Sep 17, 2026
- EUDAMED 42982cc3-65c2-4692-9cf4-fbd212f6a726 61 fields · synced May 16, 2026
- EUDAMED e42baaf7-d4df-4934-a166-7579b023bce0 61 fields · synced May 17, 2026
- EUDAMED 88ee970e-fdf6-4957-b34d-a18708a65497 61 fields · synced May 17, 2026
- EUDAMED 94f99965-8029-450a-9151-14d86a1ae8f9 61 fields · synced May 17, 2026
- EUDAMED 5e45261b-927e-441c-8093-7bc73a2be965 61 fields · synced May 17, 2026
- EUDAMED b08a542e-0ee9-49f1-ab88-bdf15f55c8be 61 fields · synced May 17, 2026
- EUDAMED f01bd0b5-2612-47f1-8288-7320b79003f1 61 fields · synced May 17, 2026
- EUDAMED ef2f7a58-47d4-4a13-9e76-6823f43bbe24 61 fields · synced May 18, 2026
- EUDAMED 60fe0982-5b90-4392-bd54-48076fe7dadb 61 fields · synced May 18, 2026
- EUDAMED 99c6783b-54f1-4abc-a42a-20d59f97abbb 61 fields · synced May 18, 2026
- EUDAMED 4043c1cf-84fe-4ba4-bf18-eb2d77bc8396 61 fields · synced May 18, 2026
- EUDAMED 1b2b961a-738c-4e83-96ef-bbe5b2f6e463 61 fields · synced May 19, 2026