Reamer mit Handgriff-Sortiment
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Reamer mit Handgriff-Sortiment EUDAMEDEDENTA FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Endo-Instrumente EUDAMEDReamer with handle-assortment FDA UDI
- Model / Reference
- 16411 EUDAMED171.25.654SO2 EUDAMEDFDA UDI
- Description
- Reamer with handle-assortment FDA UDI
Identifiers
- Primary DI / UDI-DI
- E31217125654SO21 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216411DS EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Manual endodontic file/rasp, reusable
Reamer mit Handgriff-Sortiment by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
- REAMERS — DiaDent Group International · Class I
- K-Files — MICRO MEGA · Class I
- Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216411DS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 86931a49-3212-44ea-9118-6f72750d2d41 61 fields · synced Jun 18, 2026
- FDA UDI 6892cbd4-19b8-4de1-b5ae-8d09adf9bd53 33 fields · synced May 30, 2026