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Limas K
EUDAMEDClass IIa (EU MDR)
Ref ZKFILE2120Model Limas K 21mm 20 (6 uds.)Ref ZKF25ASST2Model Limas K 25mm surtidas 45-80 (6 uds.)Ref ZKFILE2115Model Limas K 21mm 15 (6 uds.)Ref ZKFILE2106Model Limas K 21mm 06 (6 uds.)
Identity
- Trade Name
- Limas K EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas K 21mm 20 (6 uds.) EUDAMEDZKFILE2120 EUDAMEDLimas K 25mm surtidas 45-80 (6 uds.) EUDAMEDZKF25ASST2 EUDAMEDLimas K 21mm 15 (6 uds.) EUDAMEDZKFILE2115 EUDAMEDLimas K 21mm 06 (6 uds.) EUDAMEDZKFILE2106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050934 EUDAMED06975718051122 EUDAMED06975718050927 EUDAMED06975718050897 EUDAMED
- Basic UDI-DI
- B-06975718050934 EUDAMEDB-06975718051122 EUDAMEDB-06975718050927 EUDAMEDB-06975718050897 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMEDQ030311 ENT SURGERY RASPS AND FILES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Limas K 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-06975718050934 | 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 (4)
- EUDAMED ec15eff5-3215-4be8-9a06-ec285704bf3f 61 fields · synced Sep 18, 2026
- EUDAMED ba272740-468d-4a7b-a081-e7311d2a868e 61 fields · synced May 18, 2026
- EUDAMED a3362b6b-d341-4e10-bdf9-d58593df4184 61 fields · synced May 18, 2026
- EUDAMED 6418df4c-cd47-4962-8f91-7fdfc2ddef51 61 fields · synced May 19, 2026