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Fix Konisch Surgical Tray
EUDAMEDClass I (EU MDR)
Ref FK6301Model TrayModel Dental Accessory
Identity
- Trade Name
- Fix Konisch Surgical Tray EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Tray EUDAMEDFK6301 EUDAMEDDental Accessory EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525163581 EUDAMEDD-DEMF000009412FK6301EB EUDAMED
- Basic UDI-DI
- 426052516EmptyKitDC EUDAMEDB-DEMF000009412FK6301EB EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Instrument tray, reusable
Fix Konisch Surgical Tray by Medigma Biomedical Gmbh — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 426052516EmptyKitDC | Class I | Active |
| EUDAMED | European Union | CE/MDR | 426052516EmptyKitDC | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED 3ffc1670-78ea-40b0-b44e-76585e846da4 61 fields · synced Jul 28, 2026
- EUDAMED c31ec9f9-018f-49e2-b238-42edd5d69ebc 61 fields · synced May 19, 2026