Identity
- Trade Name
- Ishraq Surgico EUDAMED
- Device Name
- Endodontics Instruments EUDAMED
- Model / Reference
- 701-1907 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G44570119070 EUDAMED
- Basic UDI-DI
- ++G445ENDODONTICSINSTRUWU EUDAMED
- Direct Marketing DI
- +G44570119070 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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: Manual endodontic file/rasp, reusable
Ishraq Surgico by Ishraq Surgico — Class I — MDR — listed in EUDAMED — 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G445ENDODONTICSINSTRUWU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ishraq Surgico
- EUDAMED SRN
- PK-MF-000010674
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 607b3c00-7583-47af-8eae-c4d4a69f6d02 61 fields · synced Jun 19, 2026