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iTi Finger Spreaders
EUDAMEDClass IIa (EU MDR)
Ref CODE422535Model E42 NiTi Finger Spreaders 6s 25mm No.35
Identity
- Trade Name
- iTi Finger Spreaders EUDAMED
- Device Name
- Dental Root Canal Instruments Pluggers EUDAMED
- Model / Reference
- E42 NiTi Finger Spreaders 6s 25mm No.35 EUDAMEDCODE422535 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512506271 EUDAMED
- Basic UDI-DI
- B-06942512506271 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
iTi Finger Spreaders by Shenzhen Denco Medical Co., Ltd. — Class IIa — 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-06942512506271 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 30811b89-916e-46c3-9a4c-90a79f82bea6 61 fields · synced Jul 17, 2026