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Excalibur PRO Mini sterile files
EUDAMEDClass IIa (EU MDR)
Ref ZRE21PROMI25Model Excalibur PRO Mini sterile files 21mm E25 (6 units)Ref ZRE31PROMI20Model Excalibur PRO Mini sterile files 31mm E20 (6 units)Ref ZRE25PROMI20Model Excalibur PRO Mini sterile files 25mm E20 (6 units)Ref ZRE31PROMI25Model Excalibur PRO Mini sterile files 31mm E25 (6 units)
Identity
- Trade Name
- Excalibur PRO Mini sterile files EUDAMED
- Device Name
- Excalibur PRO Mini sterile files EUDAMED
- Model / Reference
- Excalibur PRO Mini sterile files 21mm E25 (6 units) EUDAMEDZRE21PROMI25 EUDAMEDExcalibur PRO Mini sterile files 31mm E20 (6 units) EUDAMEDZRE31PROMI20 EUDAMEDExcalibur PRO Mini sterile files 25mm E20 (6 units) EUDAMEDZRE25PROMI20 EUDAMEDExcalibur PRO Mini sterile files 31mm E25 (6 units) EUDAMEDZRE31PROMI25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512514955 EUDAMED06942512514986 EUDAMED06942512514962 EUDAMED06942512514993 EUDAMED
- Basic UDI-DI
- B-06942512514955 EUDAMEDB-06942512514986 EUDAMEDB-06942512514962 EUDAMEDB-06942512514993 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 Mini 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-06942512514955 | 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 92b3129d-e227-4d1b-84bc-e2c1ecd65208 61 fields · synced Jul 13, 2026
- EUDAMED 661c9110-8b0e-42e4-a879-67115a2a4c5b 61 fields · synced May 18, 2026
- EUDAMED 8dc79f20-6397-4bd0-8f0d-bff47fe87e4b 61 fields · synced May 18, 2026
- EUDAMED 4965355b-3a5d-45bb-b92b-d894653bc21c 61 fields · synced May 18, 2026