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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

TF TOPFIL

UDI-DI 08800206600354Basic UDI-DI 88002066HAFV3

Class III · MDR · Koru Pharma Co., Ltd

Identification
Model
AVALON
EMDN
X0303
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR.2292-2025/0030

EU technical documentation assessment · unknown

Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)

Valid from 2026-09-18 · Expiry 2030-12-09

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Koru Pharma Co., Ltd

SRN KR-MF-000037958

KR · Dongsan-myeon, Chuncheon-si, Gangwon-do

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/tf-topfil-0354 · UDI page: /udi/08800206600354

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