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Excalibur PRO sterile files
EUDAMEDClass IIa (EU MDR)
Ref TKZRE25PRO25Model Excalibur PRO sterile files 25mm E25 Training Kit
Identity
- Trade Name
- Excalibur PRO sterile files EUDAMED
- Model / Reference
- Excalibur PRO sterile files 25mm E25 Training Kit EUDAMEDTKZRE25PRO25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512509685 EUDAMED
- Basic UDI-DI
- B-06942512509685 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), 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
Excalibur PRO sterile files 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-06942512509685 | 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 9c49d3e8-84bd-4941-ae40-f16517a74066 61 fields · synced Jun 19, 2026